Highlighted Reports
MedSun: Newsletter #66, November 2011

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 August 1 through August 31, 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.



CARDIOVASCULAR


Device:
Type: Sheath, Removal, Pacemaker Electrode
Manufacturer: Spectronectics
Brand: Sls Ii
Model#: 500-001
Lot #: C11D21B
Other #: P002566-03

Problem:
A lead extraction procedure was being performed to remove two pacemaker leads implanted 11 years ago. There was one right atrial and one right ventricular lead. The Spectronetics machine was turned on and calibrated appropriately. A 12 French SLS II laser sheath was connected to the machine and the calibration button was pushed with no response. It was repeated multiple times with no calibration done effectively. The Spectronetics rep was called and instructed us to wipe off the sensor with alcohol and dry. This was re-attempted with no success. They asked us to clear the sensor on the laser machine and use the control sheath which calibrated fine. The laser sheath would still not calibrate. The rep then informed us to use another 12 FR Laser sheath. We instituted a new 12 FR laser sheath that calibrated fine without difficulty.


Device:
Type: Zoll Pacemaker/defibrillator Pd 1400
Manufacturer: Zoll Medical Corporation
Brand: Zoll
Model#: PD 1400

Problem:
A patient presented to the Emergency Department (ED) undergoing CPR (cardiopulmonary resuscitation). Patient was in asystole for a few minutes then went into a ventricular tachycardia rhythm that could be defibrillated. The ED RN charged the defibrillator, with sync button on the first time and accidentally pushed the buttons on the paddles instead of the multifunction cable to discharge. It did not discharge for this known reason the first time. The RN turned off the machine (defibrillator) and recharged without the sync button, pushing the buttons on the multifunction cable to discharge and the discharge did not occur. The first RN enlisted the Charge RN to double check everything and the device would not discharge with the 3rd attempt either. A new device was then used and worked fine. Patient's condition was such that the short delay did not contribute to this patient's demise. It is known that the equipment is greater than 10 years old so is most likely getting to its end of use time. It is also known that in the heat of the moment, there could have been something performed incorrectly, although we will never know. The RNs involved are skilled and detailed. Report is being made in case others might have the same issue.


GENERAL & PLASTIC SURGERY


Device:
Type: Absorbable Hemostat
Manufacturer: Medafor, Inc.
Brand: Arista Ah Absorbable Hemostat
Lot #: W1601418, W1579122

Problem:
Physicians have reported that their patients developed small lymphocysts after Arista Absorbable Hemostat was used.


Device:
Type: Electrosurgical, Cutting & Coagulation & Accessories
Manufacturer: CONMED CORPORATION
Lot #: 110114
Cat #: 138105

Problem:
The surgeon was using the needle tip with the electrosurgical handpiece during the procedure; Brand: ConMed., REF# 138105, Lot # 110114. The handpiece was plugged into the argon beam unit and the settings were for coagulation and cut, set to 40/40 and on blend. The needle tip was found to be melted after use by the surgeon. Biomed engineering was informed and came to inspect the needle tip and argon beam electrosurgical generator. Biomed evaluated the argon beam machine and found it to be in proper working function. Biomed determined that the current settings used for this handpiece needle tip exceeded recommended settings of 25 W. Settings as noted were 40/40. Communication to all Surgeons by the Surgical QA chair regarded the proper settings intended for the specific needle tip. There is no indication on the needle tip packaging to indicate the proper settings for the generator. Nor are there recommendations from ConMed as to specific settings for specific needle tips.

See device images:

Image of two ConMed Bovie Tips.  One is shown with a brownish melted needle tip; the other Bovie Tip is not melted.

 Second view of two ConMed Bovie Tips.  One is shown with a brownish melted needle tip; the other Bovie Tip is not melted.

Device:
Type: Needle, Suturing
Manufacturer: Arthrex Inc
Brand: Multifire Scorpion Needle
Model#: AR-13995N
Lot #: 409680A
Cat #: AR-1399SN

Problem:
Needle improperly tempered resulting in misfire of suture passing. All in lot were found to be abnormal. Surgeon has seen same problem at another surgicenter, suggesting widespread problem.


Device:
Type: Negative Pressure Wound Therapy System
Manufacturer: Kinetic Concepts, Inc.
Model#: 60090

Problem:
Wound vac pump running off battery power even with the power cord plugged in. Battery was not charging with the power cord plugged in.

See device images:


This image shows the power cord correctly plugged into the Wound VAC system.  The plug is correctly plugged in because there is a indicator light on, which shows that the Wound VAC system is operating on AC/DC power.

 This image is a close up, which shows the power cord correctly plugged into the Wound VAC system.  The plug is correctly plugged in because there is a indicator light on, which shows that the Wound VAC system is operating on AC/DC power.  The white arrow found on the power cord faces the indicator light.

This image is a close up of the power cord plugged into the Wound VAC system.  This time, the cord is not correctly plugged in because no indicator light is on.



Device:
Type: Sponge, Gauze
Manufacturer: Surgicount Medical
Brand: 18 X18 Master Tagged Lap Sponge
Lot #: 8009
Cat #: SM-1818-PS

Problem:
Circulating RN opened a package of lap sponges to give up to the scrub person and upon opening inner wrapper, noted several (more than 2) black specks on the laps. She did not pass the laps up to the sterile field, and removed them from the room.


Device:
Type: Stapler, Skin
Manufacturer: Ethicon Endo-Surgery, Inc.
Brand: Proximate
Model#: PXW35
Lot #: H43V95
Cat #: PXW35

Problem:
Stapler 1 of 3 misfired during the same procedure.


Device 1:
Type: Stapler, Skin
Manufacturer: Ethicon Endo-Surgery, Inc.
Brand: Proximate Plus Md
Model#: PMW35
Lot #: H4421K
Cat #: PMW35

Device 2:
Type: Stapler, Skin
Manufacturer: Ethicon Endo-Surgery, Inc.
Brand: Proximate Plus Md
Model#: PMW35
Lot #: H43Y7Y
Cat #: PMW35

Problem:
Patient was having a non-emergent cesarean section and during closure the OB doctor was attempting to use the Proximate Plus MD skin stapler. Three staplers needed to be opened. The first 2 staplers would not release staples but the 3rd did. Per the OB Nurse and Nurse Manager, the patient experienced a prolonged time for the incision to be open. Other risks include: increased risk for breaking sterile field due to staff having to open numerous staplers before finding one that would work and increased risk for infection.

Manufacturer response for Stapler, Skin, Proximate Plus MD (per site reporter): Manufacturer is sending replacements at no charge and they are sending a "return shipper kit" to us so that we can ship back the defective staplers for QA.


OBSTETRICS/GYNECOLOGY


Device:
Type: Clamp, Circumcision
Manufacturer: Cardinal Health

Lollipop Icon


Problem:
This one-day-old healthy newborn male was to undergo a routine circumcision performed by an experienced obstetrician. During the placement of the bell and clamp, the physician was not satisfied with the components of the first circumcision tray components so requested another tray be opened. She interchanged the clamp while leaving the bell in place, and therefore did not check if the new components fit together properly. During her first cut the instrument slipped causing a degloving injury of the shaft of the penis.

The standard practice in this facility is the use of Gomco surgical instruments assembled in a tray (circumcision) that is returned and re-sterilized in the Central Processing Department on campus. The exception to this rule is the use of the plastic bell device used by the pediatric surgeons in the NICU and pediatrics. However, some disposable sets were left in OB to be used on a trial basis as instrument trays were always readily available for use. Despite these being identified as "disposable," the appearance of components of the kit looked very similar to the reusable ones that are in use on a routine basis. With careful inspection, it was questioned if these disposable items were returned to Central Processing as a result was inter-mixed with the Gomco product.

After careful inspection of the instruments, it was noted that the bells differed in length by approximately 3 mm. This could lead to a clamp that is not proper and safe for use in the procedure.

The disposable kits were taken off the shelf immediately. Those physicians credentialed in circumcision procedure were notified that the Gomco components are not interchangeable. The Plastic bell device will continue to be supported by the pediatric surgeons.





~~~
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.


MedSun Newsletters are available at www.fda.gov/cdrh/medsun