BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GORE SUTURE PASSER

    MDR report key: 1894060 · Received November 4, 2010

    Report

    Report Number
    MW5018070
    Event Type
    Malfunction
    Date Received
    November 4, 2010
    Date of Event
    October 1, 2010
    Report Date
    October 7, 2010
    Manufacturer
    GORE
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    NEEDLE TIP OF GORE SUTURE PASSER BROKE OFF IN PT ABDOMINAL WALL. MD RETRIEVED THE NEEDLE TIP. AN ADDITIONAL LARGER INCISION NEEDED TO BE MADE TO RETRIEVE THE SMALL TIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GORE SUTURE PASSER SUTURE PASSER GCJ GORE 1GSP02

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR