BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH ENDOSCOPIC LINEAR CUTTER

    MDR report key: 89068 · Received May 4, 1997

    Report

    Report Number
    1527736-1997-00828
    Event Type
    Malfunction
    Date Received
    May 4, 1997
    Report Date
    April 29, 1997
    Manufacturer
    ETHICON ENDO-SURGERY, INC.
    Product Code
    GAG
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    H6; CODE 400: DAMAGED FIRING MECHANISM. FACILITY EXPERIENCED AN EVENT WITH THE ENDOPATH ENDOSCOPIC LINEAR CUTTER WHILE PERFORMING A LAP OOPHALERCTOMY. THE PRODUCT COMPLAINT ANALYSIS TEAM HAS COMPLETED ITS INVESTIGATION OF THE DEVICE WHICH WAS RETURNED TO CO WITH PRODUCT INQUIRY #972456-2. THE RESULTS OF THE INVESTIGATION CONDUCTED BY THE APPROPRIATE ENGINEERS AND TECHNICIANS ARE LISTED BELOW. VISUAL INSPECTIONS & RESULTS: LOCKOUT POSITION, BROKEN; CARTRIDGE CONDITION, PARTIALLY FIRED; CARTRIDGE RETURN BATCH NUMBER, H00181; AND INSTRUMENT NUMBER, 009. FUNCTIONAL TESTS & RESULTS: CONDITION OF FIRING TRIGGER LOCKOUT, CONDITION OF PINION GEAR, CONDITION OF SHORT RACK, AND CONDITION OF YOKE, GOOD; AND WAS INSTRUMENT CYCLED, NO. ANALYSIS CONCLUSION: BASED UPON THE INFO RECEIVED AND THE VISUAL EXAMINATION, IT WAS CONCLUDED THAT THE INSTRUMENT WAS RETURNED NON-FUNCTIONAL. THE INSTRUMENT WAS DISASSEMBLED AND FOUND TO HAVE A DAMAGED FIRING MECHANISM. NO CONCLUSION COULD BE REACHED AS TO HOW THIS DAMAGE OCCURRED. DUE TO THE DAMAGED FIRING MECHANISM THE INSTRUMENT MAY BECOME DIFFICULT TO RELEASE FROM TISSUE. SOME CONDITIONS WHICH MIGHT RESULT IN DAMAGE TO THE FIRING MECHANISM ARE: INTERRUPTED FIRING CYCLE, TISSUE THICKER THAN INDICATED, ATTEMPTING TO FIRE THROUGH A SPENT CARTRIDGE, FIRING PRIOR TO COMPLETE CLAMPING OF THE JAWS AND FAILURE TO PROPERLY FOLLOW REOADING INSTRUCTIONS. CO STRIVES TO UNDERSTAND EACH INCIDENT AS IT OCCURS IN ORDER TO CONTINUOUSLY IMPROVE THE PRODUCTS.

    Description of Event or Problem · 1

    THE INSTRUMENT WAS USED DURING A LAPAROSCOPIC OVARIAN CYSTECTOMY. IT WAS REPORTED THE INSTRUMENTS WOULD NOT FIRE PROPERLY, A CRUNCHING SOUND WAS HEARD, AND THERE WAS DIFFICULTY RELEASING THE ANVIL FROM THE TISSUE. THE CASE WAS COMPLETED WITHOUT THE EZ35. THERE WAS NO CONSEQUENCE TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOPATH ENDOSCOPIC LINEAR CUTTER ENDOSCOPIC LINEAR CUTTER GAG ETHICON ENDO-SURGERY, INC. NA H41H6K

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other