BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDO STITCH 10MM SUTURING DEVICE

    MDR report key: 1365963 · Received February 4, 2009

    Report

    Report Number
    1219930-2009-00072
    Event Type
    Malfunction
    Date Received
    February 4, 2009
    Report Date
    January 13, 2009
    Manufacturer
    NORTH HAVE - USS
    Product Code
    MFJ
    PMA / PMN Number
    K934738
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PROCEDURE TYPE: LAP NISSEN. ACCORDING TO THE REPORTER: THE NEEDLE WOULD TOGGLE THEN FALL OUT OF THE DEVICE; ONE NEEDLE GOT STUCK IN THE TISSUE THEN CAME OFF THE DEVICE. A NEW INSTRUMENT WAS USED TO COMPLETE THE PROCEDURE. THE NEEDLES WERE REMOVED FROM THE PT. NO SIGNIFICANT DELAY TO SURGERY. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDO STITCH 10MM SUTURING DEVICE DISPOSABLE SUTURING DEVICE MFJ NORTH HAVE - USS UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1