BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH LINEAR CUTTERS

    MDR report key: 122169 · Received September 23, 1997

    Report

    Report Number
    1527736-1997-02343
    Event Type
    Malfunction
    Date Received
    September 23, 1997
    Report Date
    August 25, 1997
    Manufacturer
    ETHICON ENDO-SURGERY, INC.
    Product Code
    KOG
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE RESULTS OF THE INVESTIGATION CONDUCTED BY THE APPROPRIATE ENGINEERS AND TECHNICIANS ARE LISTED BELOW: VISUAL INSPECTIONS & RESULTS: ANY OTHER NOTICABLE DAMAGE NO, BATCH NUMBER K00W52, CARTRIDGE PAN IN PLACE/CONDITION YES/GOOD, CONDITION OF DRIVERS GOOD, LOCKOUT TABS ON PAN CONDITION BENT, POSITION/CONDITION OF WEDGE SLEDS PARTIALLY FIRED. FUNCTIONAL TESTS & RESULTS: CONDITION OF CLAMPING 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, RESULT OF ATTEMPTED FIRING GOOD. ANALYSIS CONCLUSION: BASED UPON THE INQUIRY INFO RECEIVED, THE VISUAL EXAMINATION, AND THE FUNCTIONAL TESTING, NO CONCLUSION COULD BE REACHED AS TO WHY THE INSTRUMENT REPORTEDLY "MISFIRED" DURING SURGERY. THE INSTRUMENT WAS RETURNED IN GOOD PHYSICAL CONDITION. IT WAS CONCLUDED THAT THE INSTRUMENT WAS FULLY FUNCTIONAL AND CONFORMING TO DESIGN SPECIFICATIONS. THE EXPERIENCE THE SURGEON REPORTED COULD NOT BE REPEATED. THE RETURNED CARTRIDGE HAD A DENT IN THE WEDGE SLED AND 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 INSTRUMENT'S FIRING CYCLE IS INTERRUPTED RELEASED, THEN RESTARTED, THE CARTRIDGE WILL LOCKOUT AND A NEW CARTRIDGE SHOULD BE LOADED INTO THE INTRUMENT. 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 OUR PRODUCTS.

    Description of Event or Problem · 1

    THE TSB35 WAS USED DURING AN UNK PROCEDURE. IT WAS REPORTED THE DEVICE MISFIRED. THERE IS NO OTHER INFO AVAILABLE. THERE WAS NO CONSEQUENCE TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOPATH LINEAR CUTTERS LINEAR CUTTER KOG ETHICON ENDO-SURGERY, INC. NA K45V2C

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other