BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDO STITCH

    MDR report key: 3960989 · Received July 22, 2014

    Report

    Report Number
    MW5037423
    Event Type
    Malfunction
    Date Received
    July 22, 2014
    Date of Event
    June 18, 2014
    Report Date
    July 21, 2014
    Manufacturer
    COVIDIEN
    Product Code
    KOG
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    DEVICE WOULD NOT LOAD. SUTURE DISCONNECTED AND NEEDLE BROKE. TWO OTHER SIMILAR OCCURRENCES HAVE OCCURRED WITH THIS TYPE OF DEVICE SINCE THIS OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    429186 ENDO STITCH SUTURING DEVICE KOG COVIDIEN REF173016 J4A2075X

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR