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U.S. Department of Health and Human Services

MedSun: Newsletter #91, January 2014

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Newsletter #91, January 2014

Articles

Nipple Aspirate Test: Safety Communication

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FDA MedWatch Safety Alert

The FDA is alerting the public, including women and health care providers, that a nipple aspirate test is not a replacement for mammography, other breast imaging tests, or breast biopsy, and should not be used by itself to screen for or diagnose breast cancer. The FDA is not aware of any valid scientific data to show that a nipple aspirate test by itself is an effective screening tool for any medical condition including the early detection of breast cancer or other breast disease.

Additional Information:

Nipple Aspirate Test: Safety Communication. FDA MedWatch Safety Alert. December 12, 2013.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm378489.htm

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CO2 Multi Absorber by Vital Signs Devices: Field Corrective Action

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FDA MedWatch Safety Alert

Vital Signs Devices, a GE Healthcare Company, has initiated a voluntary field corrective action of the disposable Multi Absorber Original after becoming aware of a potential safety issue due to air leakage associated with the CO2 Multi Absorber. The Multi Absorber Original may have a thin wall condition which may lead to small holes in the water (drain tube). This may result in a loss of anesthetic gases, ventilation and oxygenation. Vital Signs is following up with all customers and will replace all affected units at no cost to customers.

Additional Information:

CO2 Multi Absorber by Vital Signs Devices: Field Corrective Action. FDA MedWatch Safety Alert. January 1, 2014.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm380134.htm

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Nephros Filtration Products: Class I Recall

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FDA MedWatch Safety Alert

The Nephros In-Line Dual Stage Ultra (DSU) Filter is a disposable filter that delivers microbiologically pure water for washing and drinking. The DSU Filter is not a complete water treatment system but it serves to remove biological contaminants. Promotional materials for non-medical water filtration products were determined to promote claims which constitute marketing the product as a medical device. The affected marketing materials include the following document numbers: 60-0237 Nephros Ultrafilters Technical Dossier (Infection Control) and 60-3003 Nephros In-Line DSU Filter Brochure.


Additional Information:

Nephros Filtration Products: Class I Recall. FDA MedWatch Safety Alert. January 7, 2014.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm380473.htm

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Truebalance and Truetrack Blood Glucose Meters by Nipro Diagnostics: Recall

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FDA MedWatch Safety Alert

The company determined that certain isolated TRUEbalance and TRUEtrack Blood Glucose Meters have an incorrect factory-set unit of measure that displays the glucose result in mmol/L rather than mg/dl. If a consumer were not to notice the incorrect unit of measure, it is possible that the meter result could be read as a lower than expected blood glucose result. Consumers who have a TRUEbalance or TRUEtrack meter should check to confirm if they have an affected TRUEbalance or TRUEtrack meter by obtaining the serial number from the serial number label on the back of the meter and visiting www.NiproDiagnostics.com/product-notice or by calling Stericycle toll-free at 1-866-236-4518.

Additional Information:

Truebalance and Truetrack Blood Glucose Meters by Nipro Diagnostics: Recall. FDA MedWatch Safety Alert. January 8, 2014.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm380758.htm

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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 December 2013. All other reports can be searched under the ‘MedSun reports’ menu pane.


Device:
Type: Apparatus, Suction, Operating-room
Manufacturer: Stryker Endoscopy
Brand: Strykeflow Ii
Model#: (not provided)
Lot #: 13285FG2
Cat #: 250-070-500
Other #: (not provided)

Problem:
Per RN Reporter: When disconnecting the Stryker suction irrigator battery compartment from the irrigation bag at the end of the case, I noticed a moderate amount of brown fluid dripping out of the compartment. I opened the compartment, and saw that the bottom of the compartment was wet, and there was either rust or corrosion from the batteries present. The batteries also had rust/corrosion on the bottom. I notified the Stryker rep, and he came in to investigate. He took pictures of the irrigator and sent them to Stryker. Device was given to the Stryker rep. He is going to complete an incident with Stryker. The physician also was notified of this incident. No change to the patient's plan of care at this time.


Device:
Type: Blood/fluid Warmer
Manufacturer: Smiths Medical ASD. Inc
Brand: Level 1
Model#: (not provided)
Lot #: 2588659
Cat #: D-100
Other #: (not provided)

Problem:
Tubing is defective and will not fit into the pump. This is the second set of lot numbers this has happened to. Vendor notified of first event already.


Device:
Type: Bottle, Collection, Vacuum
Manufacturer: Medical Device Resource Corporation
Brand: Disposable Implosion Proof Canister
Model#: LS2-SP
Lot #: (not provided)
Cat #: LS7020
Other #: (not provided)

Problem:
Staff involved in event describe that the canister on power aspirator "exploded" spilling contents. Unit manager investigated and indicated that the canister "ruptured." Unclear if the device actually exploded or imploded. Unit manager and staff verified that the equipment was set up according to the manufacturer's instructions. Per manager, the device was set up and was initially functioning without difficulty. In the early portion of the case, the canister ruptured. There was no warning that the device was going to rupture. Contents of the canister (body fluids and fat) were splashed in the immediate zone/area and shards of the container were scattered about; however, the sterile field remained sterile and no staff members were exposed to blood/body fluids or harmed. If the rupture had occurred later in the case, the sterile field could have been compromised and the likelihood that staff would have been exposed to blood/body fluids would have been much higher. The unit manager attributes the fact that the sterile field was maintained and no staff exposure/harm were due to the event occurring early in the case and that there was not much material inside the canister at the time of the rupture.

A different liposuction machine and canisters from a different lot were used to complete case. This type of event has happened with all of this canister lot #. The unit manager and staff did not retain the lot number but have returned all of the affected lot to the manufacturer. The exact number of pieces returned to the manufacturer is unknown, although there were several.

The settings on the suction device (flow rate and vacuum setting) are unknown. Per the unit manager, the liposuction machine that was involved in this event was checked and found to be in full working order. It was returned to use and has had no problems. The staff and surgeons that use this equipment are experienced in using it.

The unit manager requested this event be reported after speaking with the manufacturer's representative. The rep indicated that this type of problem with ruptured canisters had occurred recently at more than one facility.

======================
Manufacturer response for Power Aspirator, Power Aspirator (per site reporter)
======================
The manager notified the rep and the rep came and took all the product of that lot # that has malfunctioned.



Device:
Type: Bottle, Collection, Vacuum
Manufacturer: Medical Device Resource Corporation
Brand: Disposable Implosion Proof Canister
Model#: LS2-SP
Lot #: (not provided)
Cat #: LS7020
Other #: (not provided)

Problem:
Staff involved in event describe that the canister on power aspirator "exploded" spilling contents. Unit manager investigated and indicated that the canister "ruptured." Unclear if the device actually exploded or imploded. Unit manager and staff verified that the equipment was set up according to the manufacturer's instructions. Per manager, the device was set up and was initially functioning without difficulty. In the early portion of the case, the canister ruptured. There was no warning that the device was going to rupture. Contents of the canister (body fluids and fat) were splashed in the immediate zone/area and shards of the container were scattered about; however, the sterile field remained sterile and no staff members were exposed to blood/body fluids or harmed. If the rupture had occurred later in the case, the sterile field could have been compromised and the likelihood that staff would have been exposed to blood/body fluids would have been much higher. The unit manager attributes the fact that the sterile field was maintained and no staff exposure/harm were due to the event occurring early in the case and that there was not much material inside the canister at the time of the rupture.

A different liposuction machine and canisters from a different lot were used to complete case. This type of event has happened with all of this canister lot #. The unit manager and staff did not retain the lot number but have returned all of the affected lot to the manufacturer. The exact number of pieces returned to the manufacturer is unknown, although there were several.

The settings on the suction device (flow rate and vacuum setting) are unknown. Per the unit manager, the liposuction machine that was involved in this event was checked and found to be in full working order. It was returned to use and has had no problems. The staff and surgeons that use this equipment are experienced in using it.

The unit manager requested this event be reported after speaking with the manufacturer's representative. The rep indicated that this type of problem with ruptured canisters had occurred recently at more than one facility.

======================
Manufacturer response for Power Aspirator, Power Aspirator (per site reporter)
======================
The manager notified the rep and the rep came and took all the product of that lot # that has malfunctioned.


Device:
Type: Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days
Manufacturer: Edwards Lifesciences Corp
Brand: Centurion Multi-med
Model#: (not provided)
Lot #: 2013070950
Cat #: M3716KIC
Other #: 7F 16 cm .032

Problem:
The event occurred while inserting a right subclavian central line. After obtaining venous access, the guide wire was passed easily and dilation was completed without incident. In the process of attempting to insert the 16fr central line catheter, the line could not be advanced past 6cm. Wire was reassessed and still found to be passing easily. A 20fr central line catheter was obtained and was easily inserted without incident, post-procedure XR confirms correct placement. After the procedure I inspected the 16 Fr catheter and discovered that there was a foreign body within the lumen of the catheter at about the 6cm point. The foreign body was blue plastic, probably about 1cm in length. The catheter itself was entirely intact with no external pieces chipped off or missing. I gave this foreign body to the patient's nurse who then took it to quality control. The patient is doing well at this time with no apparent complications.

Unfortunately, the foreign body was maintained and not the catheter. If the manufacturer would find this useful, we would be able to send pending release from our legal services department.


Device:
Type: Indicator, Physical/chemical Sterilization Process
Manufacturer: 3M COMPANY
Brand: 3m Comply
Model#: 70200703075
Lot #: 10208-030
Cat #: 13913
Other #: (not provided)

Problem:
Sterile Processing Department Director noted that the Comply Instrument protector, which resides in the sets when sharp instruments such as hooks, etc... (and are needed in the set). An orange substance has been observed on the card upon opening the set(s). It is the Ethylene Oxide (EO) chemical indicator which is on the card and should not run during sterilization, but has done so.
The company who manufactures these has given us the following instructions:
"If you find one of the cards shown below in which the EO chemical indicator on the protector card has run (orange on left side), please consider the set contaminated. We will replace the set. But the set does need to be re-processed. No Flashing should be done if this is noted (not necessary)"
We don't yet know why it has occurred. We have pulled all the lot numbers involved but there will be some of these protectors still found in sets.


Device:
Type: Insert, Tubal Occlusion
Manufacturer: CONCEPTUS, INC.
Brand: Essure
Model#: ESS305
Lot #: B53550
Cat #: (not provided)
Other #: (not provided)

Problem:
While attempting to place the Essure system into the Fallopian tubes bilaterally, there were problems deploying the coils into the tubes and a piece of one of the catheters broke off while trying to remove the catheter from the patient. The piece was retrieved by the physician.


Device:
Type: Pump, Infusion
Manufacturer: Smiths Medical
Brand: Medfusion 4000
Model#: 4000
Lot #: (not provided)
Cat #: (not provided)
Other #: (not provided)

Problem:
Communication from manufacturer to Biomed:
This message is in follow-up to your recent contact regarding three Medfusion Keypads (part no.: 40-5768-51A.) You had reported the following issue: "I had a Medfusion 4000 came in with a keypad error last week. I tested it and noticed the 7, 8, 9, 0, . , and 'back' keys were not functioning. While troubleshooting, I put one of our spare 3500 keypads on the unit to test, and the same six keys were still malfunctioning while the rest worked. Two more 4000s arrived in the shop with notes saying keypad error. After testing the units the exact same six keys were the only ones malfunctioning."Keep in mind that the model 3500 keyboard is exactly the same keyboard used in the 3500.

There was no incident report filed because it seemed like routine failure of the pump to the staff. It was discovered after the fact by our biomedical engineering technician that there were 3 units that demonstrated the same failure within a couple of days. The devices are approximately 3 months old (each one). This facility has had multiple issues with these pumps since introducing them into the facility. We continue to work with the manufacturer.

======================
Manufacturer response for Medfusion 4000 Infusion Pump, Medfusion 4000 (per site reporter)
======================
Product complaint file MPAU 168829-com has been opened to document this occurrence. If the components are available to be returned for investigation, please send the samples using Smiths Medical FedEx account to the below address and provide the package tracking number.


Device:
Type: Pump, Infusion
Manufacturer: Smiths Medical
Brand: Medfusion 4000
Model#: 4000
Lot #: (not provided)
Cat #: (not provided)
Other #: (not provided)

Problem:
Communication from manufacturer to Biomed:
This message is in follow-up to your recent contact regarding three Medfusion Keypads (part no.: 40-5768-51A.) You had reported the following issue: "I had a Medfusion 4000 came in with a keypad error last week. I tested it and noticed the 7, 8, 9, 0, . , and 'back' keys were not functioning. While troubleshooting, I put one of our spare 3500 keypads on the unit to test, and the same six keys were still malfunctioning while the rest worked. Two more 4000s arrived in the shop with notes saying keypad error. After testing the units the exact same six keys were the only ones malfunctioning."Keep in mind that the model 3500 keyboard is exactly the same keyboard used in the 3500.

There was no incident report filed because it seemed like routine failure of the pump to the staff. It was discovered after the fact by our biomedical engineering technician that there were 3 units that demonstrated the same failure within a couple of days. The devices are approximately 3 months old (each one). This facility has had multiple issues with these pumps since introducing them into the facility. We continue to work with the manufacturer.

======================
Manufacturer response for Medfusion 4000 Infusion Pump, Medfusion 4000 (per site reporter)
======================
Product complaint file MPAU 168829-com has been opened to document this occurrence. If the components are available to be returned for investigation, please send the samples using Smiths Medical FedEx account to the below address and provide the package tracking number.


Device:
Type: Pump, Infusion
Manufacturer: Smiths Medical
Brand: Medfusion 4000
Model#: 4000
Lot #: (not provided)
Cat #: (not provided)
Other #: (not provided)

Problem:
Communication from manufacturer to Biomed:
This message is in follow-up to your recent contact regarding three Medfusion Keypads (part no.: 40-5768-51A.) You had reported the following issue: "I had a Medfusion 4000 came in with a keypad error last week. I tested it and noticed the 7, 8, 9, 0, . , and 'back' keys were not functioning. While troubleshooting, I put one of our spare 3500 keypads on the unit to test, and the same six keys were still malfunctioning while the rest worked. Two more 4000s arrived in the shop with notes saying keypad error. After testing the units the exact same six keys were the only ones malfunctioning."Keep in mind that the model 3500 keyboard is exactly the same keyboard used in the 3500.

There was no incident report filed because it seemed like routine failure of the pump to the staff. It was discovered after the fact by our biomedical engineering technician that there were 3 units that demonstrated the same failure within a couple of days. The devices are approximately 3 months old (each one). This facility has had multiple issues with these pumps since introducing them into the facility. We continue to work with the manufacturer.

======================
Manufacturer response for Medfusion 4000 Infusion Pump, Medfusion 4000 (per site reporter)
======================
Product complaint file MPAU 168829-com has been opened to document this occurrence. If the components are available to be returned for investigation, please send the samples using Smiths Medical FedEx account to the below address and provide the package tracking number.


Device:
Type: System, Balloon, Intra-aortic And Control
Manufacturer: MAQUET
Brand: Cs300
Model#: D998-00-3023-53
Lot #: (not provided)
Cat #: (not provided)
Other #: CS300, English, 110V

Problem:
The machine alarmed "rapid air loss" while attached to the patient. After several minutes the message read "blood detected". The machine ceased pumping and a new machine had to be retrieved for the patient.
The manufacturer inspected the device and confirmed there was condensation in the IAB fill line. There was no explanation as to why the condensation occurred and this machine has had two such errors.


Device:
Type: System, Suction, Lipoplasty
Manufacturer: Medical Device Resource Corporation
Brand: Power Aspirator
Model#: LS2-SP
Lot #: (not provided)
Cat #: (not provided)
Other #: (not provided)

Problem:
Staff involved in event describe that the canister on power aspirator "exploded" spilling contents. Unit manager investigated and indicated that the canister "ruptured." Unclear if the device actually exploded or imploded. Unit manager and staff verified that the equipment was set up according to the manufacturer's instructions. Per manager, the device was set up and was initially functioning without difficulty. In the early portion of the case, the canister ruptured. There was no warning that the device was going to rupture. Contents of the canister (body fluids and fat) were splashed in the immediate zone/area and shards of the container were scattered about; however, the sterile field remained sterile and no staff members were exposed to blood/body fluids or harmed. If the rupture had occurred later in the case, the sterile field could have been compromised and the likelihood that staff would have been exposed to blood/body fluids would have been much higher. The unit manager attributes the fact that the sterile field was maintained and no staff exposure/harm were due to the event occurring early in the case and that there was not much material inside the canister at the time of the rupture.

A different liposuction machine and canisters from a different lot were used to complete case. This type of event has happened with all of this canister lot #. The unit manager and staff did not retain the lot number but have returned all of the affected lot to the manufacturer. The exact number of pieces returned to the manufacturer is unknown, although there were several.

The settings on the suction device (flow rate and vacuum setting) are unknown. Per the unit manager, the liposuction machine that was involved in this event was checked and found to be in full working order. It was returned to use and has had no problems. The staff and surgeons that use this equipment are experienced in using it.

The unit manager requested this event be reported after speaking with the manufacturer's representative. The rep indicated that this type of problem with ruptured canisters had occurred recently at more than one facility.

======================
Manufacturer response for Power Aspirator, Power Aspirator (per site reporter)
======================
The manager notified the rep and the rep came and took all the product of that lot # that has malfunctioned.


Device:
Type: Ventilator, Continuous, Facility Use
Manufacturer: DRAEGER MEDICAL SYSTEMS, INC.
Brand: Evita Infinity V500
Model#: Infinity V500
Lot #: (not provided)
Cat #: (not provided)
Other #: (not provided)

Problem:
Without warning, the ventilator showed an error message "disk failure, please replace internal disk" and just shut off. There was a nurse and respiratory therapist nearby, who immediately began bagging the patient. The respiratory therapist did hear an alarm that was loud and constant, and not the "normal" alarm. This alarm was not immediate but came on after the ventilation had been off for a period of time.

The ventilator was evaluated and being repaired by a Drager tech under the supervision of our Biomedical Engineering Dept.

Device:
Type: Heart-valve, Non-allograft Tissue
Manufacturer: Sorin Group USA, Inc.
Brand: Mitroflow
Model#: (not provided)
Lot #: (not provided)
Cat #: 12A21
Other #: Size 21mm aortic pericardial heart valve

Problem:
Surgeon who removed the valve believes it should have lasted more than 4 years. He believes the failure has both product and patient factors involved; he did not give me more information on why he specifically believed that to be the case.
From the operative note:
Indications: This patient who previously underwent coronary artery bypass grafting x3 approximately ten years ago, and subsequently underwent #21 mitral flow prosthesis to the aortic position approximately four years ago. The patient initially did very well with normal postoperative echocardiography. Subsequently she developed shortness of breath and congestive heart failure symptoms consistent with aortic stenosis. Serial echocardiography documented early degeneration of the valve prosthesis. Left ventricular function had decreased to 40-45% and previously placed coronary grafts were widely patent and the cardiac function was dependent on these grafts. Evaluation by the percutaneous valve team determined that she was not a candidate for valve in valve placement.
Findings at surgery: The patient was found to have dense pericardial adhesions and the previous grafts were widely patent and high flow. Pulmonary artery pressures were in the 55-60 systolic range with left ventricular ejection fraction in the 40% range and inferior hypokinesis noted. Mild mitral regurgitation was seen. The aorta was friable and calcific. The aortic anulus was also quite friable and weak. The previous prosthesis was noted to be calcified and largely immobile. The pericardium leaflets did not have vegetations but were quite stiff and could be opened with difficulty only with direct handling. The very small anulus was scar in the 19 prosthesis was placed with some tearing of the anulus requiring removal of the first prosthesis attempted at operation and placement of a second #19 prosthesis with pledgeted sutures. Left ventricular function was initially sluggish but recovered rapidly following separation from cardiopulmonary bypass. In the interim an intra-aortic balloon pump was placed through the left groin by Seldinger technique to allow for full ventricular recovery. At the close of the procedure the patient had absence of much regurgitation no discernible aortic insufficiency and recovery of left ventricular function.

Manufacturer response for Pericardial Aortic Heart Valve, Mitroflow Aortic pericardial Heart valve (per site reporter)
======================
No response to date.


Device:
Type: Apparatus, Suction, Single Patient Use
Manufacturer: Cardinal Health
Brand: Jackson-pratt Reservoir
Model#: unk
Lot #: unk
Cat #: (not provided)
Other #: (not provided)

Problem:
Potential for infection due to stopper not in place
Defective Jackson-Pratt reservoir SU 130-1305 Cardinal Health
Doctor brought a defective reservoir from a patient he saw in his office. This patient had four drains/reservoirs. In Dr's office at the time of the removal of the drains, it was noted that three of the reservoirs had the yellow rubber stopper inside the reservoir. This is a safety issue due to the fact that stopper prevents flow back into the drain tube.


Device:
Type: Implant, Customized, Craniomaxillofacial
Manufacturer: Stryker Orthopedics
Brand: (not provided)
Model#: (not provided)
Lot #: K08702VR21FEB
Cat #: 5444-0-400
Other #: (not provided)

Problem:
Patient was scheduled for right cranioplasty. A custom made implant was ordered for the patient. The custom implant was sent from the company to its representative in a large sealed box. On four sides of the box is a label that includes a REF # and LOT # and description of the contents, e.g. Customized implant, Host bone and 2 X-Large implants.

There are no patient identifiers on the external sealed box. The company representative, who was expecting this custom implant (and had no other custom implants pending receipt for this hospital), wrote the surgeon's name, the patient's name and date of surgery on the top of the external box.

When the large box was opened during surgery, it contained 3 smaller boxes: one box contained the host bone 'model,' and two boxes contained the custom implant and a spare custom implant. Each implant was contained in a separate box and in sterile packaging with similar labeling as on the outside of the large box.

When the package was opened to the sterile field, the surgeon noted that the custom implant was for the left side. Subsequently, while looking through the large box, a 'Design Proposal' document was located and included the name of a different patient and surgeon.


Device:
Type: System, Surgical, Computer Controlled Instrument
Manufacturer: Intuitive Surgical, Inc.
Brand: Davinci Single Site Permanent Cautery Hook
Model#: 428090
Lot #: na
Cat #: 428090
Other #: (not provided)

Problem:
Single site hook cautery snapped on insertion and instrument was unusable. Brand new instrument. Ref 428090. Surgeon initiated the dissection; however, one of the instruments was not functional and we had to place an additional port in the left abdomen to use a third arm from the robot. This was the first single port daVinci case that has been done at this hospital. Because of this there was only one set of instruments available without backups. Case would have been optimized if we had a replacement single hook cautery. With no back up instrument we had to improvise and make another incision.


Device:
Type: System, Surgical, Computer Controlled Instrument
Manufacturer: Intuitive Surgical
Brand: Endowrist Hot Shears
Model#: 420179
Lot #: M11130802
Cat #: (not provided)
Other #: (not provided)

Problem:
While undocking robot at the conclusion of a robotic assisted radical nephrectomy, scrub nurse noticed a bulge under the scissor tip cover of the robotic endowrist. Scissor tip was difficult to remove. Instrument was passed off the sterile field, when removed; multiple pieces of the endowrist shaft were found to be loose under the scissor tip. Surgeon notified. Laparoscope used to view the surgical field and evaluated for loose pieces remaining. None noted, area thoroughly irrigated and suctioned out. Remaining pieces of instrument were collected.

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Updated January 1, 2014

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