BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    APPEL NEEDLE HOLDERS LEFT CURVE 5MM, 32CM LIGATION

    MDR report key: 3241202 · Received November 28, 2006

    Report

    Report Number
    2430952-2006-00041
    Event Type
    Malfunction
    Date Received
    November 28, 2006
    Report Date
    October 6, 2006
    Manufacturer
    GS-VERPACKUNGSFOLIE
    Product Code
    KOG
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT THE DEVICE WAS USED DURING A LAPAROSCOPIC SUTURE WITHIN THE ABDOMINAL CAVITY. THE TIP OF THE DEVICE BROKE OFF. NO PATIENT INJURY WAS REPORTED. REFERENCE MFR REPORT # 8010877-2006-00006.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 APPEL NEEDLE HOLDERS LEFT CURVE 5MM, 32CM LIGATION JARIT ENDOSCOPIC INSTRUMENT KOG GS-VERPACKUNGSFOLIE

    Patients

    Seq Age Sex Outcome Treatment
    1