BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDO STITCH 10MM SUTURING DEVICE

    MDR report key: 1112755 · Received August 11, 2008

    Report

    Report Number
    1219930-2008-00600
    Event Type
    Malfunction
    Date Received
    August 11, 2008
    Date of Event
    June 30, 2008
    Report Date
    July 16, 2008
    Manufacturer
    NORTH HAVEN - USS
    Product Code
    MFJ
    PMA / PMN Number
    K934738
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PROCEDURE TYPE: LAP GASTRIC BYPASS. ACCORDING TO THE REPORTER: THE TIP OF THE NEEDLE BROKE AWAY FROM THE DEVICE AND FELL INTO THE CAVITY. THE NEEDLE PIECE WAS FOUND AND REMOVED WITH A GRASPER DURING THE CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDO STITCH 10MM SUTURING DEVICE DISPOSABLE SUTURING DEVICE MFJ NORTH HAVEN - USS N8D158

    Patients

    Seq Age Sex Outcome Treatment
    1