BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONMED

    MDR report key: 1162762 · Received September 15, 2008

    Report

    Report Number
    MW5008316
    Event Type
    Malfunction
    Date Received
    September 15, 2008
    Date of Event
    August 27, 2008
    Report Date
    September 15, 2008
    Manufacturer
    CONMED ELECTROSURGERY
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    EQUIPMENT MALFUNCTION. DR STATED THE ABC -ARGON BEAM COAGULATOR - PROBE DID NOT SEEM TO BE WORKING PROPERLY. THE PROBE WAS REMOVED FROM USE AND EXAMINED. THE TIP THAT SHOULD BE BLUNT WAS FOUND TO HAVE A SHARP NEEDLE TIP PROTRUDING FROM WITHIN THE BLUNT TIP. PROBE WAS REMOVED FROM THE SURGICAL FIELD AND SENT FOR EVAL. DR THOROUGHLY EXAMINED THE OPERATIVE SITE AND FOUND NO APPARENT INJURY TO THE PT. IN 2008 - RN - PHOTO'S WERE TAKEN OF THE INSTRUMENT & PHOTOS, THE PACKAGE & HAND PIECE WERE SENT TO BIOMED AFTER THE HAND PIECE WAS DECONTAMINATED & HIGH LEVEL DISINFECTED. THE GYN. NURSE SPECIALIST CONTACTED THE CONMED TO SEE IF THEY MFR A NEEDLE TIP PROBE/HANDPIECE & THEY DO NOT. THE ABC PROBE/HANDPIECE STOCK WAS CHECKED - MATERIALS, CENTRAL SUPPLY, AND OR - FOR ANY OTHER PROBES THAT MIGHT HAVE THE SAME LOT # 080206-1. ONE OTHER PROBE/HANDPIECE WITH THE SAME LOT NUMBER WAS LOCATED. THE PACKAGE WAS OPENED TO COMPARE THE PROBES. ON INSPECTION, THE 2ND PROBE APPEARED TO HAVE NOTHING SHARP PROTRUDING FROM THE END. THE BIOMED DEPT EXAMINATION OF THE 1ST -DEFECTIVE- PROBE REVEALED THE SHAFT OF THAT PROBE WAS SHORTER, 1/4" APPROX., THAN THE OTHER PROBE FROM THE SAME LOT NUMBER. ON THE SAME DAY, THE EVENT WAS REPORTED BY TELEPHONE TO THE CONMED QA DEPT AND THEY ISSUED A RGA NUMBER TO RETURN THE DEFECTIVE PROBE. THEY WERE TOLD WE WERE HOLDING THE DEVICE UNTIL WE WERE CERTAIN THERE WAS NO PT INJURY - THE POTENTIAL FOR BOWEL PERFORATION EXISTED-. ON THREE DAYS LATER, THE PT WAS SEEN IN THE EMERGENCY DEPT WITH ABDOMINAL PAIN AND FOR THAT REASON WE ARE NOT RELEASING THE PROBE USED DURING THE PROCEDURE. ON THE FOLLOWING MONTH, FURTHER EXAMINATION OF THE 2ND PROBE THAT HAD APPEARED TO BE FREE OF DEFECTS, REVEALED THAT THERE WAS A TINY SHARP NEEDLE-LIKE TIP JUST BARELY VISIBLE AND WHEN RUNNING A FINGER OVER THE END OF THE PROBE THE SHARP TIP COULD BE FELT. FOLLOWING THAT DISCOVERY A PROBE FROM A DIFFERENT LOT NUMBER WAS OPENED AND EXAMINED VISUALLY AND MANUALLY, AND THERE WAS NOTHING DETECTABLE PROTRUDING FROM THE TIP. IT IS APPARENT THAT THERE IS MORE THAN ONE DEFECTIVE PROBE FROM THE LOT # 080206-1. CONMED WAS NOTIFIED OF THE 2ND DEFECTIVE PROBE. ON THE NEXT DAY, THE 2ND DEFECTIVE PROBE, PACKAGE, AND PHOTO OF THE 1ST DEFECTIVE PROBE WERE SENT TO CONMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONMED ARGON BEAM COAGULATOR - ELECTROSURGICAL UNIT HANDPIECE GEI CONMED ELECTROSURGERY ABC PROBE 5 MM X 28 U80206-1

    Patients

    Seq Age Sex Outcome Treatment
    1