BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH ETS-FLEX45

    MDR report key: 2487891 · Received March 6, 2012

    Report

    Report Number
    MW5024583
    Event Type
    Malfunction
    Date Received
    March 6, 2012
    Date of Event
    January 28, 2012
    Report Date
    March 6, 2012
    Manufacturer
    ETHICON ENDO-SURGERY
    Product Code
    GDW
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    MD USING ARTICULATING ENDOSCOPE CUTTER FOR APPENDECTOMY. WHEN THE MD PRESSED THE BUTTON, THE HANDLE CONTROL CRUMBLED AND MD WAS MOMENTARILY UNABLE TO DETACH THE EQUIPMENT FROM THE APPENDIX. AFTER MANEUVERING FOR A FEW MINUTES, THE APPENDIX WAS RELEASED WITHIN THE PT AND THE BROKEN PIECE WAS REMOVED. A 2ND INSTRUMENT, SAME KIND, WAS USED AND WORKED WITHOUT DIFFICULTY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOPATH ETS-FLEX45 LINER CUTTER GDW ETHICON ENDO-SURGERY H44T08

    Patients

    Seq Age Sex Outcome Treatment
    1 6 YR Other