BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH ETS

    MDR report key: 110984 · Received August 6, 1997

    Report

    Report Number
    1527736-1997-01907
    Event Type
    Malfunction
    Date Received
    August 6, 1997
    Date of Event
    June 26, 1997
    Report Date
    July 9, 1997
    Manufacturer
    ETHICON ENDO-SURGERY, INC.
    Product Code
    KOG
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    H6; CODE 400: DAMAGED CLOSING AND FIRING MECHANISM/BENT CARTRIDGE LOCKOUT TAB. FACILITY EXPERIENCED AN EVENT WITH YOUR ENDOPATH* ETS ON 6/26/97 WHILE PERFORMING AN UNKNOWN PROCEDURE. THE PRODUCT COMPLAINT ANALYSIS TEAM HAS COMPLETED ITS INVESTIGATION OF THE DEVICE WHICH WAS RETURNED TO US WITH PRODUCT INQUIRY # 974233. THE RESULTS OF THE INVESTIGATION CONDUCTED BY THE APPROPRIATE ENGINEERS AND TECHNICIANS ARE LISTED BELOW. VISUAL INSPECTIONS & RESULTS: BATCH NUMBER, AB K00R2F; CARTRIDGE PAN IN PLACE/CONDITION, AB YES/GOOD; CONDITION OF DRIVERS, AB GOOD; LOCKOUT TABS ON PAN CONDITION, A BENT B GOOD AND POSITION/CONDITION OF WEDGE SLEDS, AB PARTIALLY FIRED. FUNCTIONAL TESTS & RESULTS: CONDTION OF CLAMP FIRST LOCKOUT, GOOD; CONDITION OF CLAMPING MECHANISM, GOOD; CONDITION OF FIRING MECHANISM, BROKEN; CONDITION OF KNIFE, GOOD; CONDITION OF WEDGE BANDS, GOOD AND IS HYPER LOCKOUT CONDITION PRESENT, 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. THE RETURNED CARTRIDGE "A" HAD A BENT LOCIOUT TAB ON THE PAN WHICH INDICATES THAT THE INSTRUMENT'S FIRING CYCLE WAS INTERRUPTED, RELEASED, THEN RESTARTED. WHEN THIS OCCURRED, THE LOCKOUT TAB ON THE CARTRIDGE BECAME DAMAGED. IF THE INSTRUMENT'S FIRING CYCLE IS INTERRUPTED, RELEASED, THEN RESTARTED, THE CARTRIDGE WILL LOCKOUT AND A NEW CARTRIDGE SHOULD BE LOADED INTO THE INSTRUMENT. EACH INSTRUMENT IS EVALUATED DURING THE ASSEMBLY PROCESS TO ENSURE IT FUNCTIONS PROPERLY. CO STRIVES TO UNDERSTAND EACH INCIDENT AS IT OCCURS IN ORDER TO CONTINUOUSLY IMPROVE CO'S PRODUCTS.

    Description of Event or Problem · 1

    THE CIN RECEIVED WRITTEN CORRESPONDENCE FROM THE SURGEON REGARDING THIS EVENT. IT WAS REPORTED THE DEVICE WAS USED DURING AN UNKNOWN PROCEDURE. IT WAS REPORTED "THE STAPLING DEVICE WORKED WELL FOR THREE APPLICATIONS. ON THE FOURTH APPLICATION, THE STAPLES DID NOT FIRE, AND THE KNIFE DID NOT CUT." THERE WAS NO DANGER TO THE PATIENT. "THE ONLY DIFFICULTY EXPERIENCED WAS OPERATIVE TIME EXTENSION WHILE WAITING TO OBTAIN A SECOND STAPLING DEVICE AND COMPLETE THE TASK." THERE WAS NO CONSEQUENCE TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOPATH ETS LINEAR CUTTER KOG ETHICON ENDO-SURGERY, INC. NA K46189

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other