BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH ETS

    MDR report key: 91604 · Received May 15, 1997

    Report

    Report Number
    1527736-1997-00950
    Event Type
    Malfunction
    Date Received
    May 15, 1997
    Date of Event
    April 18, 1997
    Report Date
    May 14, 1997
    Manufacturer
    ETHICON ENDO-SURGERY, INC.
    Product Code
    KOG
    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: BENT CARTRIDGE LOCK OUT TABS. FACILITY EXPERIENCED AN EVENT WITH EDDOPATH ETS WHILE PERFORMING A UNKNOWN PROCEDURE. THE PRODUCT COMPLAINT ANALYSIS TEAM HAS COMPLETED ITS INVESTIGATION OF THE DEVICE WHICH WAS RETURNED TO US WITH PRODUCT INQUIRY #972521. THE RESULTS OF THE INVESTIGATION CONDUCTED BY THE APPROPRIATE ENGENEERS AND TECHNICIANS ARE LISTED BELOW. VISUAL INSPECTIONS & RESULTS: BATCH NUMBER K00R0F, CARTRIDGE PAN IN PLACE/CONDITION YES/GOOD, CONDITION OF DRIVERS GOOD, LOCKOUT TAB ON PAN CONDITION BENT, POSITION/CONDITION OF WEDGE SLEDS 1/3 FIRED/GOOD. FUNCTIONAL TESTS & RESULTS: CONDITON OF CLAMP FIRST LOCKOUT GOOD, CONDITION OF CLAMPING MECHANISM GOOD, CONDITION OF FIRING MECHANISM GOOD, CONDITION OF KNIFE GOOD, CONDITION OF WEDGE BANDS GOOD, IS HYPER LOCKOUT CONDITION PRESENT NO. ANALYSIS CONCLUSION: BASED UPON THE INQUIRY INFO RECEIVED, THE VISUAL EXAMINATION, AND THE FUNCTIONAL TESTING, NO CONCLUSIION COULD BE REACHED AS TO WHY THE INSTRUMENT REPORTEDLY "JAMMED" DURING SURGERY. THE INSTRUMENT WAS RETURNED IN GOOD PHYSICAL CONDITION. IT WAS CONCLUDED THAT THE INSTRUMENT WAS FULLY FUNCTIONAL AND CONFORMING TO DESIGN SPCECIFICATIONS. THE EXPERIENCE THE SURGEON REPORTED COULD NOT BE REPEATED. THE RETURNED CARTRIDGE HAD A BENT LOCKOUT 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 CARTRIDE WILL LOCKOUT AND A NEW CARTRIDGE SHOULD BE LOADED INTO THE INSTRUEMNT. 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 THE PROUDCTS.

    Description of Event or Problem · 1

    THE DEVICE WAS USED DURING AN UNKNOWN PROCEDURE. IT WAS REPORTED BY THE AFFILIATE THAT THE DEVICE JAMMED. IT WAS ALSO REPORTED THAT THE DEVICE DID NOT CUT. THERE WAS NO PT CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOPATH ETS LINEAR CUTTER KOG ETHICON ENDO-SURGERY, INC. NA K45Y3A

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other