BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDO STITCH

    MDR report key: 2141456 · Received June 21, 2011

    Report

    Report Number
    2141456
    Event Type
    Malfunction
    Date Received
    June 21, 2011
    Date of Event
    June 17, 2011
    Report Date
    June 21, 2011
    Manufacturer
    COVIDIEN
    Product Code
    OCW
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    VT, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE PATIENT UNDERWENT A LAPAROSCOPIC NISSEN FUNDOPLICATION AND REPAIR OF A HIATUS HERNIA. DURING THE SUTURING, THE ENDOSCOPIC NEEDLE BROKE OFF FROM THE ENDO STITCH. AN ABDOMINAL FILM DID NOT REVEAL THE NEEDLE IN THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDO STITCH SUTURE DEVICE OCW COVIDIEN 173016 *
    2 ENDO STITCH, SOFSILK SUTURE DEVICE, LOAD OCW COVIDIEN 170003 *

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR