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U.S. Department of Health and Human Services

MedSun: Newsletter #60, May 2011

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Newsletter #60, May 2011

Articles

Lansoprazole Delayed-Release Orally Disintegrating Tablets by Teva Pharmaceuticals: Clogged, Blocked Oral Syringes and Feeding Tubes

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FDA MedWatch Safety Alert

The FDA has received reports that Teva's lansoprazole delayed-release orally disintegrating tablet has clogged and blocked oral syringes and feeding tubes because the tablets may not fully disintegrate.

Additional Information:

FDA Medical Device Safety. Lansoprazole Delayed-Release Orally Disintegrating Tablets by Teva Pharmaceuticals: Letter to Healthcare Professionals. April 15, 2011.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm251575.htm

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Penumbra Coil 400 by Penumbra Inc.: Class 1 Recall - Premature Detachment of the Coil

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FDA MedWatch Safety Alert

The pull wire on the coil delivery tool can slip out of place and allow premature detachment of the coil. Premature detachment of the coil may cause the coil to unintentionally migrate. This can lead to serious injury including blood clots and stroke.

Additional Information:

FDA Medical Device Safety. Penumbra Coil 400 by Penumbra Inc.: Class 1 Recall. April 13, 2011.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm251402.htm

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Axxent FlexiShield Mini by iCAD (formerly Xoft Inc.): Recall - Product May Shed Particles of Tungsten

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FDA MedWatch Safety Alert

Xoft Axxent Flexishield Mini product, Model 5300, may shed particles of tungsten. After use during Intraoperative Radiation Therapy (IORT) for in breast tissue, these particles can be mistaken for suspicious calcifications during follow up X-rays or scans.

Additional Information:

FDA MedWatch Safety Alert. Axxent FlexiShield Mini by iCAD (formerly Xoft Inc.): Recall. April 13, 2011.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm251353.htm

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Moog Recalls Curlin Ambulatory Infusion Pump Models 6000 CMS, 6000 CMS IOD, PainSmart, and PainSmart IOD

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FDA Press Release

The affected models were manufactured and updated from May 2007 to February 2011. The decision to conduct the device recall is due to a software anomaly which leads to software Error Code 45 (EC45), resulting in a shutdown of the pump. This failure may result in a delay or interruption of therapy, which could result in serious injury and/or death.

Additional Information:

FDA Press Release. Moog Recalls Curlin Ambulatory Infusion Pump Models 6000 CMS, 6000 CMS IOD, PainSmart, and PainSmart IOD. April 8, 2011.
http://www.fda.gov/Safety/Recalls/ucm250733.htm

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Heartstring II Proximal Seal System (HS-1045) by Maquet Cardiovascular, LLC: Recall

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FDA MedWatch Safety Alert

The deployment tube may detach during use due to insufficient adhesive and may result in the failure of the product to operate. This may cause serious injury and/or death. Customers were instructed to immediately examine their stocks for the affected product and discontinue distributing the affected lot.

Additional Information:

FDA MedWatch Safety Alert. Heartstring II Proximal Seal System (HS-1045) by Maquet Cardiovascular, LLC: Recall. April 1, 2011.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm249395.htm

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Mikro-Tip Angiographic Catheter, Model SPC-454D and SPC-454F by Millar Instruments Inc.: Class 1 Recall

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FDA MedWatch Safety Alert

There is a possibility that small particles (debris) may be found inside the catheter. This foreign debris can potentially travel (embolize) from the catheter to tissues, blood vessels, limbs and organs. This could lead to a decreased blood supply to these structures which can result in serious injury and /or death.

Additional Information:

FDA MedWatch Safety Alert. Mikro-Tip Angiographic Catheter, Model SPC-454D and SPC-454F by Millar Instruments Inc.: Class 1 Recall. April 1, 2011.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm249387.htm

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Changes in Safety Attitude and Relationship to Decreased Postoperative Morbidity and Mortality Following Implementation of a Checklist-Based Surgical Safety Intervention

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PubMed Abstract

Improvements in postoperative outcomes were associated with improved perception of teamwork and safety climate among respondents, suggesting that changes in these may be partially responsible for the effect of the checklist. Clinicians held the checklist in high regard and the overwhelming majority would want it used if they were undergoing surgery themselves.

Additional Information:

PubMed. Changes in safety attitude and relationship to decreased postoperative morbidity and mortality following implementation of a checklist-based surgical safety intervention. January 20, 2011.
http://www.ncbi.nlm.nih.gov/pubmed/21228082

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Variation in the Rates of Adverse Events between Hospitals and Hospital Departments

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PubMed Abstract

In addition to interventions to improve the overall patient safety within a hospital, interventions tailored for specific departments are necessary to reduce their patient safety risks. Monitoring and comparing the performance of hospitals should not be limited to the hospital level, but should be extended to the individual department since there can be significant differences in the rates of preventable AEs between different departments within the same hospital.

Additional Information:

PubMed. Variation in the Rates of Adverse Events between Hospitals and Hospital Departments. April 23, 2011.
http://www.ncbi.nlm.nih.gov/pubmed/21227956

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The Patient Safety Initiative at America's Public Hospitals: The Year One Overview

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The Agency for Healthcare Research and Quality (AHRQ)

Despite the challenges inherent in improving patient safety, those NAPH members that participated in Phase One of the NPSF-NAPH Patient Safety Initiative at America's Public Hospitals adopted tools and strategies that are helping them create meaningful change in their organizations. The member stories included here illustrate how these hospitals used program resources in innovative ways to spread awareness and techniques to improve patient safety, instill and standardize safe practices, and improve outcomes. As the Initiative progresses, NPSF and NAPH will continue to aid members in implementing results-driven pro¬grams and achieving specific patient safety goals.

Additional Information:

The Agency for Healthcare Research and Quality (AHRQ). The Patient Safety Initiative at America’s Public Hospitals: The Year One Overview. January 2011.
http://www.naph.org/Main-Menu-Category/Publications/Patient-Safety-Initiative-Research-Brief.aspx

The Agency for Healthcare Research and Quality (AHRQ) Homepage.
http://www.ahrq.gov

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HeartNet

Indications for and Management of Inferior Vena Cava Filters

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Pennsylvania Patient Safety Advisory

FDA and other literature on IVC filters suggest that managing patients with filters, especially continued follow-up visits after filter implantation or removal, is an important part of the process in reducing complications from filters. Careful consideration of the indications for placing IVC filters, the indications for removing filters, as well as follow-up care and evaluation of patients with retrievable filters, can all help reduce the likelihood of complications following filter implantation.

Additional Information:

Pennsylvania Patient Safety Advisory. Indications for and Management of Inferior Vena Cava Filters. March 8, 2011.
http://patientsafetyauthority.org/ADVISORIES/AdvisoryLibrary/2011/mar8(1)/Pages/08.aspx

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Case report of out-of-hospital heat dissipation of an implantable cardioverter-defibrillator

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PubMed Abstract

The implantable cardioverter-defibrillator (ICD) has revolutionized the treatment of patients at risk of sudden cardiac death due to ventricular arrhythmias. Repeated studies have shown them to increase overall survival rates in patients with congestive heart failure or previous myocardial infarction and left ventricular dysfunction. We present a rare case of out-of-hospital ICD heat dissipation due to rapid battery discharge preceded by an audible popping noise.

Additional Information:

PubMed. Case Report of Out-of-Hospital Heat Dissipation of an Implantable Cardioverter-Defibrillator. February 17, 2011.
http://www.ncbi.nlm.nih.gov/pubmed/20876600?dopt=Abstract

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HomeNet

Patient Involvement in Patient Safety: How Willing are Patients to Participate?

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PubMed Abstract

Patients do not view involvement in a range of safety-related behaviors uniformly. Particular efforts are needed to encourage patients to participate in novel or challenging behaviors as these are behaviors where patients appear less inclined to take on an active role.

Additional Information:

PubMed. Patient Involvement in Patient Safety: How Willing are Patients to Participate? January 20, 2011.
http://www.ncbi.nlm.nih.gov/pubmed/21228083

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KidNet

Passive Safety Device Features 10 Times More Effective in Preventing Needlesticks

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SafetyShare newsletter, Premier healthcare alliance

This article discusses a study where evidence is presented that passive SEDs that require no input from the user are more effective than active SEDs for NSI prevention. The authors note that further studies are needed to determine whether their higher cost may be offset by savings related to fewer NSIs and to a reduced need for user training.

Additional Information:

Premier SafetyShare Newsletter. Passive Safety Device Features 10 Times More Effective in Preventing Needlesticks. February 2011.
http://www.premierinc.com/quality-safety/tools-services/safety/safety-share/02-22-full.jsp#Story-1-needlesticks

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Highlighted MedSun Reports

Highlighted Reports

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This section contains a sample of reports from all the MedSun reports received during a particular period. The reports were submitted by MedSun Representatives. In some instances the reports have been summarized and/or edited for clarity. The entries that follow represent a cross section of device-related events submitted by MedSun reporters during the period February 1 through February 28, 2011. All other reports can be searched under the ‘MedSun reports’ menu pane. Note: the two month delay is due to quality control and follow-up.


ANESTHESIOLOGY

Device:
Type: Dry Suction Water Seal Drain
Manufacturer: Atrium Medical Corp
Brand: Oasis
Model#: 3600 Single Collection

Problem:
Chest tube at 20cm Suction at shift change. Assessed system a few times during the night and orange floating detection device was at the 20 cm mark. Nurse was sitting next to patient's bed and, two hours later, noted that the orange floating detection device was only half way into monitoring section indicating suction was not at 20 cm. The system was found to have self sealed off at the blue water seal outlet which is normally open. It actually looked like it had melted prior to puncture. Same nurse set this up the day prior and is 100% confident that it did not look abnormal. Same nurse replaced the Oasis CT [Chest Tube] device with a new one. While awaiting the arrival of drain, hole was made in connector to allow suction to occur.

Night lights were not only low, dim and cool but were far away from the device. Surrounding light should not be a contributing heat factor.


CARDIOVASCULAR

Device 1:
Type: Catheter, Transluminal, Coronary Angioplasty, Percutaneous
Manufacturer: Boston Scientific
Brand: Apex Monorail 3. 5x12
Lot #: 13967846
Other #: 38959-1235

Device 2:
Type: Wire, Guide, Catheter
Manufacturer: Boston Scientific
Brand: Bmw Guidewire
Other #: 190cm; .014/190 J"

Problem:
Balloon was inserted along guidewire but balloon was unable to advance over the wire. Physician feels that wire was defective, too thick to thread the balloon.
======================
Manufacturer response for cardiac cath balloon, Apex Monorail 3.5x12: They are investigating.
======================
Manufacturer response for guidewire, BMW 190cm guidewire: They are investigating.


GENERAL & PLASTIC SURGERY

Device:
Type: Clip Applier
Manufacturer: Ethicon Endo Surgery, Inc.
Brand: Ligamax
Model#: EL5ML
Lot #: G4UH51

Problem:
A young male was taken to surgery for symptoms of cholecystitis and biliary dyskinesia. The patient was in need of LapChole procedure. Upon the surgeon using the 5mm Ethicon Ligamax Endoscopic Clip applier it misfired and would not administer the clip needed for closure to the cystic duct. There was no injury to the patient and a new clip applier was obtained to finish the procedure. The original clip applier was taken out of service and sequestered for Risk Management pick up. Patient's procedure was completed and patient was taken to PACU for recovery.


Device:
Type: Clip Applier
Manufacturer: Ethicon
Brand: Ligamax 5mm Endoscopic Muliptle Clip Applier
Lot #: G4U68Y
Cat #: EL5ML

Problem:
As reported by the OR team, the surgeon encountered difficulties with the clip applier. The handle appeared to "jam" when attempting to fire the device to apply the clip and also at the point of releasing after the clip had been placed, causing the tissue in the operative cavity to tear. The surgeon has used this particular clip applier before without any reported issues.


GENERAL HOSPITAL

Device:
Type: Catheter, Picc
Manufacturer: Vygon
Brand: Lifecath SPicc (Sil)
Lot #: S 0882 & 10101
Cat #: 2296.211
Lollipop Icon

Problem:
PICC catheter used in NICU was noted to be leaking/breaking below the secure-ment hub. The PICC catheters appear to be leaking from the same site as the breakage.
======================
Manufacturer response for PICC Catheter 1.9 Fr 30 cm, Lifecath S PICC (SIL)
======================
Picked up remaining catheters for credit.

See device image:
Image shows point where PICC catheters were leaking.  Breakage noted below the secure-ment hub. The PICC catheters appear to be leaking from the same site as the breakage.



Device:
Type: Catheter, Picc
Manufacturer: MedComp
Lot #: MBBT440
Cat #: MR17013101

Problem:
PICC line tubing that attaches at the end of the hub component broke and began leaking profusely. Break in line is not visible to the naked eye. Patient was taken to the OR for PICC exchange procedure. Procedure was successful and patient had no complications related to the procedure.

PICC lead RN verified the leak by injecting fluid through the line after it had been removed.


Device:
Type: Catheter, Picc
Manufacturer: Becton Dickinson
Brand: Bd L-cath Picc Dual Lumen Catheter
Lot #: 0027376
Cat #: 384467

Problem:
Patient became agitated with tachycardia, hypertension, and fever. Later a leaking PICC line was discovered, which had allowed loss of sedation meds, possibly allowing patient to enter withdrawal. PICC line was replaced with single lumen catheter for remainder of therapy.

This model PICC line has been observed to leak several times within the past year. Staff believes catheter will often leak after two weeks of use, but this one developed a leak after only 24 hours.
======================
Manufacturer response for PICC catheter, BD L-Cath PICC Dual Lumen Catheter
======================
Manufacturer's representative affirmed that cause of repeated leaks has been identified as inadequate glue bond where tubing joins to molded bifurcation. Redesign is in progress.


Device:
Type: Crib, Infant
Manufacturer: Hard Manufacturing
Lollipop Icon

Problem:
Bottom securing latch spring and guide broke. Clinicians are concerned that with only 3 of 4 security points working. There is a risk of the infant becoming wedged between rail and mattress.


Device:
Type: Picc, Catheter
Manufacturer: Covidien
Brand: Argyle Picc
Cat #: 43303
Lollipop Icon

Problem:
A nurse taking care of a neonate noticed blood backing up in the PICC line. TPN (Total Parental Nutrition) was supposed to be infusing, but it was not going through the PICC. The nurse said on close inspection of the device, she noticed a leak at the adaptor portion of the PICC. The PICC was discontinued. The catheter was intact.


RADIOLOGY

Device:
Type: Computed Radiography, Pacs System
Manufacturer: Philips Medical Systems
Brand: Pcr Eleva

Problem:
In our Radiology Department, a software upgrade was performed on the Philips Computed Radiography (PCR) Eleva from version PCR 1.1.5 to PCR 1.2. This upgrade was performed, beginning in late fall of 2010. On the new 1.2 version there is a small symbol that transfers over to the PACS (Picture Archive and Communications Systems). Our concern with this feature is the icon can be mistaken for the marker denoting the patient's right (R) side. On certain radiographic views, we utilize AP-PA mirroring in conjunction with a hanging protocol. In the mirroring process the icon could be placed on the patient's left side but you see the R mirror icon. In our practice, the technologists place the appropriate laterality "L" or "R" marker on the correct side but on PACS there also is the mirror icon that could be on the left side of the patient. This is of concern to us as radiologists, surgeons, clinicians may not know this is an AP-PA mirror icon and may mistake the icon for the wrong side of the patient's body. As of January 2011 the affected features have been turned off and some systems reverted to prior software.

Detailed information has been provided to the manufacturer and they have indicated they are working to resolve the issue.


Device:
Type: Ct Scanner
Manufacturer: GE Medical Systems, LLC
Brand: Ge Light Speed Ultra
Model#: GE Light Speed Ultra
Other #: GE ID 415723SCT1

Problem:
Radiology/CT technician prescribed only the chest to be imaged graphically, however scanner continued to scan abdomen and pelvis. GE contacted to evaluate the scanner. GE could not reproduce the problem and cause of event being investigated by GE.
======================
Manufacturer response, according to reporter, for CT Scanner, GE Light Speed Ultra
======================
Unable to determine if scanning was from operator issue. Table movement errors observed, but unclear as to whether this was related to the event. Cradle encoder assembly ordered. GE will monitor logs to see if cradle assembly might be needed.


Device:
Type: Gemini Gxl 16
Manufacturer: Philips Healthcare (Cleveland)
Brand: Gemini Gxl
Model#: Gemini GXL 16

Problem:
Patient to outpatient imaging for PET/CT scan utilizing nuclear med Gemini GXL 16 slice machine. Patient was injected with 14.89 mCi of FDG (fluorodeoxyglucose). When attempted to proceed with scan the system "hung up" due to software application and the bed portion of the scanner would not move. Procedure cancelled, patient rescheduled. Philips was called and was able to connect remotely and "re-initialized VME rack, completed function testing" and was able to complete tests for rest of the day. Same patient returned 1 week later to complete original test and the same exact issue happened. Patient had already been injected with 16 mCi of fluorine 18 FDG and again the scanner would not proceed with collecting images. Clinical Engineering troubleshooting issues, have requested staff to run QC check and emulation prior to injecting patient to ascertain machine will perform as expected. Philips has technician on-site this week to trouble shoot issues should any arise. Unknown at this time if patient will be rescheduled again or whether diagnostic test will be performed at another facility.

Manufacturer response, according to reporter, for Gemini GXL 16, Gemini GXL: Staff called Philips who was able to troubleshoot issue and "unfreeze" scanner. Continue to work through issues as they arise.


Device:
Type: Mri Scanner
Manufacturer: GE
Brand: Ge Hd 12. 0
Model#: GE HD 12.0
Other #: 1.5T

Problem:
Anesthesia cart brought to room (cart designed for use in MRI) and drawer was opened. One of two Allen wrenches in the drawer flew out of the drawer in the direction of the magnet. There was an unnamed patient in the tube; however, there were no injuries. The devices were removed from the MRI suite.

We have all the standard precautions in place - anteroom, signs, staff education, and special nonferrous carts for anesthesia and other nonferrous items for MRI, and screening/checking processes before anyone brings anything in. Someone erroneously put the wrench in the cart. The final check process by the MRI staff failed in this instance, and the wrenches, which are NOT supposed to be in the cart, were not discovered before bringing in the cart.


Device:
Type: Ultrasound, Diagnostic, Bladder Scanner
Manufacturer: Verathon Incorporated

Problem:
The patient had orders to be discharged after she was able to pass her voiding trial. Throughout the day she had high post void residuals, although they were improving with subsequent voids. The patient was very frustrated that the PVR (post void residual) amounts were still not low enough (169mls) for discharge and did not want to go home with a foley catheter. I discussed the matter with the doctor and he said that she was voiding large quantities (800mls) and he said that she could go home if she agreed to void every hour and set an alarm to get up to void at midnight. When I returned to the patient room with the discharge paperwork she stated that she had voided another 100 mls and wanted me to scan her bladder again. At this point she should have less than 100 mls in her bladder because a few minutes before her PVR was 169. The patient stated that she felt like she had really emptied her bladder this time. I scanned her bladder again and the readings were between 270 and 360. The patient stated that if her residuals were really that high when she felt like she was empty, than it would be best to insert a foley catheter. I inserted a foley catheter into her bladder (with good visualization) and her bladder was completely empty. It is unlikely that a patient would have a PVR of 300 range after voiding 900 mls of urine and impossible that a bladder with 300 mls of urine would result in a cath amount of zero. I believe this problem was caused by equipment error.


Device(s):
Type: X-ray Machine, Portable
Manufacturer: Fujifilm Medical Systems USA, Inc.
Brand: Fcr Go
Model#: FCR-MD 101

Problem:
On two different FCR-MD 101 portable X-ray machines during reverse movements, the devices lunged backwards. Fuji was notified and Fuji installed EPROM Ver. 28 on both machines. About a month later the same problem occurred again on both machines and pinned the operator against the wall and caused bruising of the forearm. Clinical Engineering pulled machine and inspected the front casters. The front casters were found to be dirty and causing the wheels to have stiff motion.

~~~

Lollipop Icon
Special Note: The lollipop icon distinguishes highlighted reports that describe medical device events involving neonatal or pediatric patients, or those events involving a medical device that is indicated for use in neonatal and pediatric patient populations. FDA defines pediatric patients as less than 21 years of age.

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Medical Device Problem Summaries

Summary of MedSun Reports Describing Problems With Specimen Retrieval Systems

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A Specimen Retrieval Bag is a disposable medical device used as a receptacle for the collection and extraction of tissue specimens such as the appendix, gallbladder, ovaries, fibroid tumors, other tissues and calculi during laparoscopic surgical procedures. It consists of a flexible polymer bag and an introducer that fits through a trocar port. This product is part of a specimen retrieval system defined as a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals (21 CFR pt 876.1500) and consists of various rigid or flexible instruments which are inserted into body spaces and may include an optical system for conveying an image to the user’s eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. The classification for this device is class II.

Over the past 2 years, Med Sun has received 11 adverse event reports concerning 13 Specimen Retrieval Bag devices manufactured by Ethicon Endosurgery, Applied Medical, Covidien and Anchor Products Company, Inc. The reports were submitted by 9 hospitals between April 2009 and April 2011.

The reported device problems describe the bag detaching, tearing, or failing to open. When the bag detaches or tears it fails to contain the specimen, this may extend the surgical and anesthesia time for the patient. This also increases the potential for a retained foreign object being left in the body cavity.

The reported device problems were:
• Specimen bag detachment (4)
• Specimen bag tear (4)
• Specimen bag fails to open (2)
• Breakage during use (2)
• Metal prong component breakage (1)

None of the reported events involved a patient death. The patient problem, “possible bowel perforation” was listed was reported in 1 of the 11 reports.

Of the reports that listed patient age, 1 had a patient age listed as less than 21 years and 8 had a patient age listed as greater than 21 years. Of the reports that listed patient gender, a total of 4 reports involved female patients and a total of 5 reports involved male patients.

These Med Sun reports summarized above, in addition to manufacturer, healthcare, and voluntary reports contributed to FDA awareness of the device problems.

~~~~~~~~~~~

The following 2 recalls are associated with the Specimen Retrieval Bag since April 2009. The MedSun reported events may, or may not, be involved in the recalls listed.

Recall Number: Z-1590-2011
Date Posted: 03/07/2011
Product: Anchor Tissue Retrieval System TRS175SB
Code Information: Code TRS175SB, lots P36N, P38N, P72N, P77N, P90N, P94N, P98N, Q05N, Q06N, Q11N, Q14N, Q24N, Q26N, Q36N and Q43N
Recalling Firm/Manufacturer: Anchor Products Company, Inc
Action: Class II recall. The firm, Anchor, sent an "URGENT: MEDICAL DEVICE RECALL" letter dated December 8, 2010 to all customers. The letter described the product, problem and actions to be taken. The customers were instructed to examine their inventory and return any remaining units to their distributor for replacement; and complete and return the attached ANCHOR RECALL RETURN RESPONSE FORM via fax to (314) 961-4535 or mail to: Progressive Medical, Inc., Attn: Marketing Manager, 11085 Gravois Industrial Court, St. Louis, MO 63128, even if they have no inventory. A representative of Anchor Products then visited each of the direct accounts to help them implement their sub recall of the devices from their customers. For additional information please contact: Vice President, Anchor Products Company at 1-800-543-9124 or 1-630-543-9124; and the distributor at 1-800-969-6331 or 1-314-961-4535
Distribution: Worldwide Distribution (1).

Recall Number: Z-1591-2011
Date Posted: 03/07/2011
Product: Anchor Tissue Retrieval System TRS100SB
Product 1: Anchor Tissue Retrieval System; ETO sterilized, single use disposable device; port size 10 mm, 225 mL capacity; 3 units per box; Manufacturer: Anchor Products Co., 52 Official Rd, Addison, IL 60101 U.S.A.; Ref TRS100SB
Code Information: TRS100SB, lots P05N, P07N, P11N, P13N, P19N, P20N, P23N, P25N, P29N, P30N, P31N, P34N, P37N, P41N, P42N, P43N, P44N, P46N, P47N, P48N, P49N, P51N, P52N, P53N, P55N, P56N, P57N, P58N, P60N, P61N, P66N, P68N, P69N, P71N, P75N, P78N, P85N, P90N, P94N, P94N, P96N, P98N, P99N, Q02N, Q04N, Q05N, Q06N, Q09N, Q11N, Q12N, Q13N, Q14N, Q17N, Q20N, Q23N, Q24N, Q30N, Q31N, Q36N, Q38N, Q41N, Q49N, Q50N and Q65N
Product 2: Anchor Tissue Retrieval System; ETO sterilized, single use disposable device; port size 15 mm, 1550 mL capacity; 3 units per box; Manufacturer: Anchor Products Co., 52 Official Rd, Addison, IL 60101 U.S.A.; Ref TRS175SB
Code Information: TRS175SB, lots P36N, P38N, P72N, P77N, P90N, P94N, P98N, Q05N, Q06N, Q11N, Q14N, Q24N, Q26N, Q36N and Q43N
Recalling Firm/Manufacturer: Anchor Products Company, Inc
Action: Class II recall The firm, Anchor, sent an "URGENT: MEDICAL DEVICE RECALL" letter dated December 8, 2010 to all customers. The letter described the product, problem and actions to be taken. The customers were instructed to examine their inventory and return any remaining units to their distributor for replacement; and complete and return the attached ANCHOR RECALL RETURN RESPONSE FORM via fax to (314) 961-4535 or mail to: Progressive Medical, Inc., Attn: Marketing Manager, 11085 Gravois Industrial Court, St. Louis, MO 63128, even if they have no inventory. A representative of Anchor Products then visited each of the direct accounts to help them implement their subrecall of the devices from their customers. For additional information please contact: Vice President, Anchor Products Company at 1-800-543-9124 or 1-630-543-9124; and the distributor at 1-800-969-6331 or 1-314-961-4535.
Distribution: Worldwide Distribution (2).


MedSun Reports Describing Problems with Specimen Retrieval Systems
DeviceDevice Identifiers (Catalog Nimber, Model Number, Lot Number) Event Description
Ethicon EndoSurgery LLC, Endopouch Retriever 2015-05, A94580P00, G4TA08 A 10 ml endopouch broke into 2 separate pieces while in use. Pieces retrieved, specimen retrieved with no patient injury.
Applied Medical, Inzii Retrieval System NA, CD001,1102568
During laparoscopic cholecystectomy with laparoscopic appendectomy, the retrieval bag broke. Specimens were retained in the bag fragment and were able to be removed. Remaining bag pieces were removed and examined by the surgeon who indicated all pieces had been removed.
Ethicon Endo Surgery, Endopouch Retriever NA, NA, 2014-02
Utilizing an Endopouch retriever bag to remove the gallbladder and stones, the end of the bag "popped off" into the patient. Visualized by a surgical tech at the time of separation. The remaining stones were removed with the other bags. Patient irrigated and suctioned with lactated ringers. Missing portion of bag removed.
Anchor Products Company, Laparoscopic Tissue Retrieval System TRS175SB, NA, Q06N
During a laparoscopic splenectomy, one of the two metal prongs from the tissue retrieval system broke off inside the patient and was retrieved. Small lacerations were noted on the abdominal wall peritoneum that appear to be caused by the broken end of the prong. Each of the two metal prongs has a hole for a swivel pin. The one prong broke at sides of this hole.
Ethicon Endo Surgery, Endopouch Retriever NA, NA, G4R94V
The endopouch retriever was being used to retrieve the specimen (ovary) from the abdomen when the bag tore/failed (apparently after the opening of the bag was delivered through the abdominal wall). At the same time a perforation of the bowel (rectosigmoid colon) was also detected. It is unclear if the two are at all related.
Applied Medical, Inzii Retrieval System CD001, NA, 1110525
Endo pouch 10mm bag tore open inside the patient when attempting to remove the gall bladder. The pouch was inspected for any missing pieces. There were no pieces of the pouch seen inside the patient.
Applied Medical, Inzii Retrieval System CD001, NA,1110525
Endopouch broke during use.
Applied Medical, Inzii Retrieval System CD001, CD001, 1120081 During an appendectomy, the retrieval system failed to open to retrieve the specimen. A second device was used with similar trouble but did open enough to retrieve specimen with difficulty
Covidien Endocatch Gold 173050G, NA, JOHOO28
When physician was performing a laparoscopic cholecystectomy and attempting to put the gallbladder into the Endo Pouch, the bag separated from the ring prior to getting the entire gallbladder in the bag. A second EndoPouch was opened and the same thing happened again. Both pouches had the same lot number.
Applied Medical, Inzii Retrieval System CD001, NA, 1114872
Patient was in for scheduled Laparoscopic Cholecystectomy. Surgeon used Applied Medical Inzii Retrieval System 10mm Endoscopic Pouch. The pouch tore when the surgeon was pulling the gallbladder out thru the trocar. A small piece of the pouch was retrieved from within the patient. Surgeon believes he got all pieces of the pouch out. He believes there is no harm to patient.
Applied Medical, Inzii Retrieval System CD001, NA, 1132177
Endo catch bag detached from metal ring upon deployment of device prior to specimen retrieval. The gallbladder was extracted from the umbilical port site without the use of a bag without further incident.



Additional Information:

1. Class 2 Recall – Anchor Tissue Retrieval System TRS175SB. Medical & Radiation Emitting Device Recalls. March 7, 2011.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?ID=96203

2. Class 2 Recall – Anchor Tissue Retrieval System TRS175SB. Medical & Radiation Emitting Device Recalls. March 7, 2011.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?ID=96203

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Updated May 1, 2011

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