BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GORE SUTURE PASSER

    MDR report key: 515926 · Received March 3, 2004

    Report

    Report Number
    MW1031413
    Event Type
    Malfunction
    Date Received
    March 3, 2004
    Date of Event
    January 20, 2004
    Report Date
    February 25, 2004
    Manufacturer
    W.L. GORE AND ASSOC., INC.
    Product Code
    HWQ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    ME, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    SURGEON INSERTED GORE SUTURE PASSER THROUGH LAPAROSCOPIC TROCAR INTO ABDOMEN. FRACTURE NOTED ON VIDEO MONITOR AT END OF INSTRUMENT. SURGEON ABLE TO RETRIEVE INSTRUMENT INTACT, BUT BROKEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GORE SUTURE PASSER SUTURE PASSER HWQ W.L. GORE AND ASSOC., INC. GSP01 *

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR