BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH ETS

    MDR report key: 90851 · Received May 8, 1997

    Report

    Report Number
    1527736-1997-00882
    Event Type
    Malfunction
    Date Received
    May 8, 1997
    Date of Event
    April 8, 1997
    Report Date
    May 8, 1997
    Manufacturer
    ETHICON ENDO-SURGERY, INC.
    Product Code
    KOG
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    H6; CODE 400: DAMAGED CARTRIDGE-WEDGE BYPASS. FACILITY EXPERIENCED AN EVENT WITH THE ENDOPATH ETS WHILE PERFORMING A L.A.V.H.. THE PRODUCT COMPLAINT ANALYSIS TEAM HAS COMPLETED ITS INVESTIGATION OF THE DEVICE WHICH WAS RETURNED TO CO WITH PRODUCT INQUIRY #972228. THE RESULTS OF THE INVESTIGATION CONDUCTED BY THE APPROPRIATE ENGINEERS AND TECHNICIANS ARE LISTED BELOW. VISUAL INSPECTIONS & RESULTS: BATCH NUMBER, K00T30; CARTRIDGE PAN IN PLACE/CODNDITION, YES/GOOD; CONDITION OF DRIVERS, GOOD; LOCKOUT TABS ON PAN CONDITION, FIRED; AND POSITION/CONDITION OF WEDGE SLEDS, RIGHT COMPLETE, LEFT. FUNCTIONAL TESTS & RESULTS: CONDITION OF CLAMP FIRST LOCKOUT, CONDITION OF CLAMPING MECHANISM, CONDITION OF FIRING MECHANISM, CONDITION OF KNIFE, AND CONDITOIN OF WEDGE BANDS, GOOD; AND IS HYPER LOCKOUT CONDITION PRESENT, NO. ANALYSIS CONCLUSION: BASED UPON THE INQUIRY INFO RECEIVED, THE VISUAL EXAMINATION, AND THE FUNCTIONAL TESTING, NO CONCLUSION COULD BE REACHED AS TO WHY RETURNED IN GOOD PHYSICAL CONDITION. TEH INSTRUMENT WAS CYCLED, FIRED, CUT, AND FORMED THE STAPLES WITHIN DESIGN SPECIFICATION. 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 BROKEN TOWER. NO CONCLUSION COULD BE REACHED AS TO HOW THE CARTRIDGE HAD BECOME DAMAGED. EACH INSTRUMENT IS EVALUATED DURING THE ASSMEBLY PROCESS TO ENSURE IT FUNCTIONS PROPERLY. CO STRIVES TO UNDERSTAND EACH INCIDENT AS IT OCCURS TO CONTINUOUSLY IMPROVE THE PRODUCTS.

    Description of Event or Problem · 1

    THE DEVICE WAS USED DURING A L.A.V.H. PROCEDURE. IT WAS REPORTED THAT IT WAS DIFFICULT TO REMOVE THE DEVICE AFTER IT WAS FIRED. ONCE THE DEVICE WAS REMOVED IT BECAME APPARENT THAT THE STAPLES HAD ONLY FIRED ON THE PEDICLE SIDE AND NOT ON THE INTERNAL SIDE. 18 TR35W RELOADS ARE BEING RETURNED WITH THE DEVICE (BATCH NUMBER K46539). PT WAS A 36 YEAR OLD FEMALE. IT WAS REPORTED THAT SHE WAS IN EXCELLANT PRE-OPERATIVE CONDITION. ADDITIONAL INFO RECEIVED ON 4/15/97 . IT WAS CLARIFIED THAT THE PROCEDURE WAS COMPLETED BY USING ANOTHER TSW35. THERE WAS NO PT CONSEQUENCE AND THE PT HAS BEEN DISCHARGED FROM THE HOSP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOPATH ETS LINEAR CUTTER KOG ETHICON ENDO-SURGERY, INC. NA K4608N

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Other