BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH ETS

    MDR report key: 155650 · Received March 11, 1998

    Report

    Report Number
    1527736-1998-00681
    Event Type
    Malfunction
    Date Received
    March 11, 1998
    Report Date
    February 10, 1998
    Manufacturer
    ETHICON ENDO-SURGERY, INC.
    Product Code
    KOG
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT COMPLAINT ANALYSIS TEAM HAS COMPLETED ITS INVESTIGATION OF THE DEVICE. VISUAL INSPECTIONS & RESULTS: BATCH NUMBER, K01067; CARTIDGE 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 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; RESULT OF ATTEMPTED FIRING, GOOD. ANALYSIS CONCLUSION: BASED UPON THE INQUIRY INFO REC'D, THE VISUAL EXAMINATION, AND THE FUNCTIONAL TESTING, NO CONCLUSION COULD BE REACHED AS TO WHY THE INSTRUMENT REPORTEDLY "WOULD NOT CUT" DURING SURGERY. THE INSTRUMENT WAS RETURNED IN GOOD PHYSICAL CONDITION. THE INSTRUMENT WAS CYCLED, FIRED, CUT, AND FORMED THE STAPLES WITHIN DESIGN SPEC. IT WAS CONCLUDED THAT THE INSTRUMENT WAS FULLY FUNCTIONAL AND CONFORMING TO DESIGN SPECS. 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 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.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING A LAPAROSCOPIC ABDOMINAL EXPLORATION WITH INDENTAL LAP APPENDECTOMY THE TSB35 WOULD NOT CUT TISSUE, BUT STAPLED FINE. ALTHOUGH TSW35 WAS OPENED TO FINISH THE CASE. THERE WAS NO CONSEQUENCE TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOPATH ETS LINEAR CUTTER KOG ETHICON ENDO-SURGERY, INC. NA K47955

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other