BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDO STITCH 10MM SUTURING DEVICE

    MDR report key: 594386 · Received June 9, 2004

    Report

    Report Number
    1219930-2004-00147
    Event Type
    Malfunction
    Date Received
    June 9, 2004
    Date of Event
    June 2, 2004
    Report Date
    June 3, 2004
    Manufacturer
    NORTH HAVEN USS
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    REPORTEDLY, THE SURGEON TOGGLED THE INSTRUMENT AND THE NEEDLE TORQUED IN HALF DURING THE PROCESS. HOWEVER, THE NEEDLW HALF WAS RETRIEVED FROM THE PATIENT'S BODY CAVITY. PRODECURE: LGB. PATIENT STATUS: NO INJURIES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDO STITCH 10MM SUTURING DEVICE DISPOSABLE SURGICAL SUTURING DEVICE GCJ NORTH HAVEN USS NA N4B423

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN