BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH ENDOSCOPIC LINEAR CUTTER

    MDR report key: 91180 · Received May 13, 1997

    Report

    Report Number
    1527736-1997-00935
    Event Type
    Malfunction
    Date Received
    May 13, 1997
    Date of Event
    April 15, 1997
    Report Date
    May 13, 1997
    Manufacturer
    ETHICON ENDO-SURGERY, INC.
    Product Code
    GAG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    D6: DEVICE RETURNED WITH NO LOT# ID. FACILITY EXPERIENCED AN EVENT WITH YOUR ENDOPATH ENDOSCOPIC LINEAR CUTTER WHILE PERFORMING A GASTRIC BYPASS. THE PRODUCT COMPLAINT ANALYSIS TEAM HAS COMPLETED ITS INVESTIGATION OF THE DEVICE WHICH WAS RETURNED TO CO WITH PRODUCT INQUIRY #972617. THE RESULTS OF THE INVESTIGATION CONDUCTED BY THE APPROPRIATE ENGINEERS AND TECHNICIANS ARE LISTED BELOW. VISUAL INSPECTIONS & RESULTS: CARTRIDGE CONDITION; 20% FIRED. CARTRIDGE RETURNED BATCH #; ED0067. CONDITION OF KNIFE, CONDITION OF WEDGES, FIRING HANDLE CONDITION, AND IS KNIFE PRESENT; GOOD. LOCKOUT INDICATOR; FIRED. STAPLES PRESENT IN INSTRUMENT; NO. FUNCTIONAL TESTS & RESULTS: WAS INSTRUMENT CYCLED; NO. ANALYSIS CONCLUSION: BASED UPON THE INQUIRY INFO RECEIVED AND THE VISUAL EXAMINATION, IT WAS CONCLUDED THAT THE REPORTED INCIDENT MAY HAVE BEEN CAUSED BY DAMAGE TO THE INTERNAL COMPONENTS. THE INSTRUMENT WAS RETURNED NON-FUNCTIONAL. THE INSTRUMENT WAS DISASSEMBLED AND WAS FOUND TO HAVE A BROKEN FIRING BELT. NO CONCLUSION BE REACHED AS TO HOW THIS DAMAGE OCCURRED. EACH INSTRUMENT IS EVLAUATED DURING THE ASSEMBLY PROCESS TO ENSURE IT FUNCTIONS PROPERLY. CO STRIVES TO UNDERSTAND EACH INCIDENT AS IT OCCURS IN ORDER TO CONTINUOUSLY IMPROVE THE PRODUCTS.

    Description of Event or Problem · 1

    THE DEVICE WAS USED DURING A LAPAROSCOPIC GASTRIC BYPASS PROCEDURE. IT WAS REPORTED THAT THE DEVICE WORKED DURING THE FIRST FIRING, BUT ON THE SECOND FIRING THE KNIFE WOULD NOT GO THROUGH THE CARTRIDGE. THERE WAS NO PT CONSEQUENCE. THE CASE WAS COMPLETED BY USING A NEW DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOPATH ENDOSCOPIC LINEAR CUTTER ENDOSCOPIC LINEAR CUTTER GAG ETHICON ENDO-SURGERY, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other