BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDO STITCH

    MDR report key: 3960982 · Received July 22, 2014

    Report

    Report Number
    MW5037424
    Event Type
    Malfunction
    Date Received
    July 22, 2014
    Date of Event
    July 14, 2014
    Report Date
    July 21, 2014
    Manufacturer
    COVIDIEN
    Product Code
    KOG
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    PHYSICIAN BEGAN USE OF ENDOSTITCH DEVICE AND IT WORKED WELL. AFTER RELOADING OF ENDOSTITCH, THE SUTURING DEVICE WOULD NOT WORK. STAFF HAD EXPERIENCED A SIMILAR ISSUE WITH A PRIOR ENDOSTITCH DEVICE AND DISCUSSED POSSIBILITY OF A BAD LOT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    429073 ENDO STITCH SUTURING DEVICE KOG COVIDIEN REF173016 J4B1727X

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR