BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDO STITCH SHORT INSTRUMENT

    MDR report key: 963171 · Received December 10, 2007

    Report

    Report Number
    1219930-2007-00800
    Event Type
    Malfunction
    Date Received
    December 10, 2007
    Report Date
    November 1, 2007
    Manufacturer
    NORHT HAVEN - USS
    Product Code
    MFJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INITIAL REPORT SENT TO FDA ON 12/10/2007.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER: THE NEEDLE WAS BROKEN FROM THE SURGIDAC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDO STITCH SHORT INSTRUMENT NONE MFJ NORHT HAVEN - USS N5L52

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK YR