BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURGIDAC POLESTER SINGLE STITCH RELOAD

    MDR report key: 2945955 · Received January 28, 2013

    Report

    Report Number
    2945955
    Event Type
    Injury
    Date Received
    January 28, 2013
    Date of Event
    January 17, 2013
    Report Date
    January 26, 2013
    Manufacturer
    COVIDIEN
    Product Code
    GAT
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    RECEIVED A CALL FROM OPERATING ROOM DIRECTOR THAT DURING SURGERY WHEN THE SURGEON WAS TRYING TO SUTURE AFTER A HIATAL HERNIA REPAIR, THE NEEDLE BROKE OFF IN THE PT. AN X-RAY WAS TAKEN AND SHOWED CLIPS AND "ONE OF THESE COULD REPRESENT NEEDLE TIP." FAMILY WAS INFORMED AND IT WAS DECIDED THAT THE ENDOSTITCH WAS IRRETRIEVABLE AND WOULD CAUSE MORE DAMAGE BY GOING AFTER IT. THE PT WENT HOME THE FOLLOWING DAY AFTER SURGERY AND HAS NOT RETURNED TO THE HOSPITAL SINCE DISCHARGE. NEEDLE WAS AN ES-9 TAPER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    37773 SURGIDAC POLESTER SINGLE STITCH RELOAD ENDOSTITCH GAT COVIDIEN J2G023OX

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR