BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDO STITCH

    MDR report key: 515949 · Received March 8, 2004

    Report

    Report Number
    MW1031432
    Event Type
    Malfunction
    Date Received
    March 8, 2004
    Date of Event
    February 10, 2004
    Report Date
    March 1, 2004
    Manufacturer
    USSC AUTO SUTURE CO.
    Product Code
    MFJ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IN, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    ENDOSTITCH INSTRUMENT BECAME JAMMED. SUTURE WAS DIFFICULT TO REMOVE. COULD NOT RE-LOAD NEW SUTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDO STITCH DISPOSABLE SUTURING DEVICE MFJ USSC AUTO SUTURE CO. * N3L364

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR