BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH ETS

    MDR report key: 153519 · Received February 25, 1998

    Report

    Report Number
    1527736-1998-00510
    Event Type
    Malfunction
    Date Received
    February 25, 1998
    Report Date
    January 27, 1998
    Manufacturer
    ETHICON ENDO-SURGERY, INC.
    Product Code
    KOG
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    D5,6; H2,3,4,6; G4: ADDED ADDITIONAL INFO. H6; ANVIL DISLODGED. PRODUCT COMPLAINT ANALYSIS TEAM HAS COMPLETED ITS INVESTIGATION OF DEVICE. RESULTS OF INVESTIGATION CONDUCTED BY APPROPRIATE ENGINEERS AND TECHNICIANS ARE LISTED BELOW. VISUAL INSPECTIONS & RESULTS: BATCH NUMBER, K01332; CARTRIDGE PAN IN PLACE/CONDITION, YES/GOOD; CONDITION OF DRIVERS, GOOD; LOCKOUT TABS ON PAN CONDITION, BENT AND POSITION/CONDITION OF WEDGE SLEDS, FULLY FIRED. FUNCTIONAL TESTS & RESULTS: CONDITION OF CLAMP FIRST LOCKOUT, GOOD; CONDITION OF CLAMPING MECHANISM, DAMAGED; 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 AND VISUAL EXAMINATION, IT WAS CONCLUDED THAT INSTRUMENT WAS RETURNED WITH ANVIL DISLODGED FROM CLOSURE TUBE. WHEN THIS CONDITION EXISTS PRESSING RELEASE BUTTON WILL NOT OPEN INSTRUMENT. ANVIL WAS RE-ALIGNED AND INSTRUMENT WAS CYCLED, FIRED, CUT, AND FORMED STAPLES WITHIN DESIGN SPECIFICATION. NO CONCLUSION COULD BE REACHED AS TO HOW THIS DAMAGED OCCURRED. EACH INSTRUMENT IS EVALUATED DURING ASSEMBLY PROCESS TO ENSURE IT FUNCTIONS PROPERLY.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING AN UNK PROCEDURE WHILE USING THE TSW35 THE DEVICE DID NOT FIRE PROPERLY. THERE WAS NO ADD'L INFO AVAILABLE. THE HEAD NURSE REPORTS 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 K48F76

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other