BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH ETS

    MDR report key: 1960034 · Received December 16, 2010

    Report

    Report Number
    1960034
    Event Type
    Malfunction
    Date Received
    December 16, 2010
    Date of Event
    December 8, 2010
    Report Date
    December 16, 2010
    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

    DEVICE WAS USED FOR LIGATION OF PROSTATIC VESSELS. STAPLER FIRED CORRECTLY BUT STAPLE CARTRIDGE FELL OFF INSIDE PATIENT'S PELVIC CAVITY. NO HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOPATH ETS STAPLER, CUTTER, SURGICAL GDW ETHICON ENDO-SURGERY, INC. ATB35 G4U39X

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR