BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDO STITCH WITH ES-9 NEEDLE

    MDR report key: 2928455 · Received January 16, 2013

    Report

    Report Number
    2928455
    Event Type
    Malfunction
    Date Received
    January 16, 2013
    Date of Event
    May 3, 2012
    Report Date
    January 16, 2013
    Manufacturer
    COVIDIEN
    Product Code
    GAM
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE SURGEON WAS PERFORMING AN ABDOMINAL LAPAROSCOPY AND ATTEMPTED TO REPAIR THE GASTROSTOMY TUBE SITE WITH THE ENDOSTITCH; HOWEVER, THE NEEDLE BROKE AND DUE TO THE MALFUNCTION, WE ELECTED TO OPEN (LAPAROTOMY PERFORMED). IT SHOULD BE NOTED THAT BOTH HALVES OF THE NEEDLE WERE FOUND DURING THE PROCEDURE AND SALVAGED. THE PROCEDURE WAS COMPLETED AND THE PATIENT TOLERATED THE PROCEDURE WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    23899 ENDO STITCH WITH ES-9 NEEDLE SUTURE GAM COVIDIEN 173023 NLH 0615

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR