BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROXIMATE ILS

    MDR report key: 1970633 · Received May 6, 2010

    Report

    Report Number
    1970633
    Event Type
    Injury
    Date Received
    May 6, 2010
    Date of Event
    April 22, 2010
    Report Date
    May 6, 2010
    Manufacturer
    ETHICON ENDO-SURGERY, INC.
    Product Code
    GDW
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US

    Narratives

    Description of Event or Problem · 1

    DURING A LAPAROSCOPIC SURGICAL PROCEDURE AN INTRALUMINAL STAPLER (EEA) FAILED TO STAPLE AND CUT. ANASTOMOSIS TORE REQUIRING SURGEON TO CONVERT TO OPEN PROCEDURE.HEALTH PROFESSIONAL'S IMPRESSION: UNIT FAILED TO DEPLOY STAPLES AND CUT. UNIT JAMMED.MANUFACTURER RESPONSE FOR STSPLER, SURGICAL, PROXIMATE ILS:MANUFACTURER TO PICK UP AND EVALUATE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROXIMATE ILS STAPLER, SURGICAL GDW ETHICON ENDO-SURGERY, INC. * F4PG9X

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR Hospitalization| O| R