BEUDAMED
    FDA Adverse Event Other Summary report: N

    ENDOSTITCH 10MM

    MDR report key: 1324201 · Received February 19, 2009

    Report

    Report Number
    1324201
    Event Type
    Other
    Date Received
    February 19, 2009
    Date of Event
    January 28, 2009
    Report Date
    February 19, 2009
    Manufacturer
    COVIDIEN/US SURGICAL
    Product Code
    MFJ
    Report Source
    User Facility report
    Reporter Location
    NV, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PATIENT UNDERWENT LAPAROSCOPIC NISSEN FUNDOPLICATION HIATAL HERNIA REPAIR. SURGEON USED AN ENDOSTITCH TO CLOSE AN ANASTOMOSIS IN THE PATIENT WITH A SURGIDAC 0 SUTURE. AFTER LOADED AND USED ON THE TISSUE, THE NEEDLE BECAME STUCK IN THE TISSUE AND HE HAD TO CUT IT OFF THE NEEDLE, THUS LEAVING THE NEEDLE IN THE PATIENT'S TISSUES. WE REMOVED THE ENDOSTITCH AND REPLACED IT. THE SAME EVENT HAPPEN AGAIN, YIELDING 2 NEEDLES IN THE PATIENT'S TISSUE. THEY WERE NOT VISIBLE AND THEREFORE UNRETRIEVABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOSTITCH 10MM NONE MFJ COVIDIEN/US SURGICAL N8L14

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR