BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH ETS-FLEX 45

    MDR report key: 1212525 · Received October 23, 2008

    Report

    Report Number
    1212525
    Event Type
    Malfunction
    Date Received
    October 23, 2008
    Report Date
    October 23, 2008
    Manufacturer
    ETHICON ENDO-SURGERY, INC.
    Product Code
    GDW
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    ONE STAPLE CARTRIDGE FELL OFF INTO THE PATIENT DURING A LAPAROSCOPIC APPENDECTOMY. CARTRIDGE IMMEDIATELY RETRIEVED. TWO OTHER CARTRIDGES MISFIRED. LINEAR CUTTER AND NEW LARGER CARTRIDGE FUNCTIONED PROPERLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOPATH ETS-FLEX 45 LINEAR CUTTER GDW ETHICON ENDO-SURGERY, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR