BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDO STITCH 10MM SUTURING DEVICE

    MDR report key: 1365961 · Received February 4, 2009

    Report

    Report Number
    1219930-2009-00075
    Event Type
    Malfunction
    Date Received
    February 4, 2009
    Date of Event
    January 16, 2009
    Report Date
    January 16, 2009
    Manufacturer
    NORTH HAVEN - USS
    Product Code
    MFJ
    PMA / PMN Number
    K934738
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PROCEDURE TYPE: LAP NISSEN. ACCORDING TO THE REPORTER: THE NEEDLE BROKE DURING THE CASE. THIS CAUSED NO TISSUE DAMGE AND NO PT INJURY. A NEW INSTRUMENT WAS USED TO COMPLETE THE PROCEDURE. NO FURTHER INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDO STITCH 10MM SUTURING DEVICE DISPOSABLE SUTURING DEVICE MFJ NORTH HAVEN - USS N8K422

    Patients

    Seq Age Sex Outcome Treatment
    1