BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH ENDOSCOPIC VASCULAR LINEAR CUTTER

    MDR report key: 89372 · Received May 4, 1997

    Report

    Report Number
    1527736-1997-00825
    Event Type
    Malfunction
    Date Received
    May 4, 1997
    Date of Event
    April 10, 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
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    H6; CODE 400: BROKEN FIRING MECHANISM. FACILITY EXPERIENCED AN EVENT WITH THE ENDOPATH ENDOSCOPIC VASCULAR LINEAR CUTTER WHILE PERFORMING A COLOSTOMY. THE PRODUCT INQUIRY #972375. THE RESULTS OF THE INVESTIGATION CONDUCTED BY THE APPROPRIATE ENGINEERS AND TECHNICIANS ARE LISTED BELOW. VISUAL INSPECTIONS & RESULTS: LOCKOUT POSITION, A UNFIRED B FIRED; CARTRIDGE CONDITION, A UNFIRED B FULLY FIRED; CARTRIDGE RETURN BATCH NUMBER, A J0094X B J0096X; AND INSTRUMENT NUMBER, 0085. FUNCTIONAL TESTS & RESULTS: CONDITION OF FIRING TRIGGER LOCKOUT, CONDITION OF PINION GEAR, AND CONDITION OF YOKE, GOOD; AND CONDITION OF SHORT RACK, BROKEN. 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 FIRED MECHANISM. NO CONCLUSION COULD BE REACHED AS TO HOW THIS DAMAGE OCCURRED. SOME CONDITIONS WHICH 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 RELOADING INSTRUCTIONS. CO STRIVES TO UNDERSTAND EACH INCIDENT AS IT OCCURS IN ORDER TO CONTINUOUSLY IMPROVE THE PRODUCTS.

    Description of Event or Problem · 1

    THE DEVICE WAS USED DURING A COLOSTOMY PROCEDURE. IT WAS REPORTED BY THE AFFILIATE THAT THE DEVICE DID NOT WORK PROPERLY (NO MORE DETAILS AVAILABLE). THERE WAS NO PATIENT CONSEQUENCE. A EVU35 RELOAD (LOT NUMBER J42R7X) IS BEING SENT BACK WITH PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOPATH ENDOSCOPIC VASCULAR LINEAR CUTTER ENDOSCOPIC LINEAR CUTTER GAG ETHICON ENDO-SURGERY, INC. NA J42X32

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other