BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH ETS FLEX

    MDR report key: 140560 · Received December 23, 1997

    Report

    Report Number
    1527736-1997-03555
    Event Type
    Malfunction
    Date Received
    December 23, 1997
    Date of Event
    October 30, 1997
    Report Date
    November 24, 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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    H6; BENT CARTRIDGE LOCKOUT TAB. PRODUCT COMPLAINT ANLYSIS TEAM HAS COMPLETED ITS INVESTIGATION OF DEVICE WHICH WAS RETURNED. RESULTS OF INVESTIGATION CONDUCTED BY APPROPRIATE ENGINEERS AND TECHNICIANS ARE LISTED BELOW. VISUAL INSPECTIONS & RESULTS: BATCH NUMBER, K01177; CARTRIDGE PAN IN PLACE/CONDITION, YES/GOOD; CONDITION OF DRIVERS, GOOD; LOCKOUT TAB ON PAN CONDITION, BENT AND POSITION/CONDITION OF WEDGE SLEDS, FULLY FIRED. FUNCTIONAL TESTS & RESULTS: CONDITION OF CLAMLP 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 AND RESULT OF ATTEMPTED FIRING, GOOD. ANALYSIS CONCLUSION: BASED UPON INFO RECEIVED, VISUAL EXAMINATION, AND FUNCTIONAL TESTING, NO CONCLUSION COULD BE REACHED AS TO WHY INSTRUMENT REPORTEDLY "DID NOT FIRE" DURING SURGERY. INSTRUMENT WAS RETURNED IN GOOD PHYSICAL CONDITION. INSTRUMENT WAS CYCLED, FIRED, CUT, AND FORMED STAPLES WITHIN DESIGN SPECIFICATION. IT WAS CONCLUDED THAT INSTRUMENT WAS FULLY FUNCTIONAL AND CONFORMING TO DESIGN SPECIFICATIONS. EXPERIENCE SURGEON REPORTED COULD NOT BE REPEATED. RETURNED CARTRIDGE HAD BENT LOCKOUT TAB ON PAN WHICH INDICATES THAT INSTRUMENT'S FIRING CYCLE WAS INTERRUPTED, RELEASED, THEN RESTARTED. WHEN THIS OCCURRED, LOCKOUT TAB ON CARTRIDGE BECAME DAMGED. IF INSTRUMENT'S FIRING CYCLE IS INTERRUPTED, RELEASED, THEN RESTARTED, CARTRIDGE WILL LOCKOUT AND NEW CARTRIDGE SHOULD BE LOADED INTO INTRUMENT. EACH INSTRUMENT IS EVALUATED DURING ASSEMBLY PROCESS TO ENSURE IT FUNCTIONS PROPERLY.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING A PELVISCOPY WHILE USING AN ATW35 THE DEVICE DID NOT FIRE TWICE. THERE IS NO FURTHER INFO AT THIS TIME. THERE WAS NO CONSEQUENCE TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOPATH ETS FLEX LINEAR CUTTER KOG ETHICON ENDO-SURGERY, INC. NA K4731X

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other