BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDO STITCH 10MM

    MDR report key: 3973006 · Received July 29, 2014

    Report

    Report Number
    MW5037536
    Event Type
    Malfunction
    Date Received
    July 29, 2014
    Date of Event
    July 28, 2014
    Report Date
    July 28, 2014
    Manufacturer
    COVIDIEN
    Product Code
    KOG
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    COVIDIEN ENDO STITCH AUTO SUTURING DEVICE WAS NOT FUNCTIONING PROPERLY DURING SET UP OF THE INSTRUMENT TABLE. IT WAS NOT LOADING THE COVIDIEN SURGIDAC 2-0 ES-9 TAPER NEEDLES AND GETTING STUCK WHEN THIS WAS ATTEMPTED. THIS ISSUE DID NOT REACH THE PATIENT. DATES OF USE: (B)(6) 2014. DIAGNOSIS OR REASON FOR USE: LAPAROSCOPIC ROUX EN Y GASTRIC BYPASS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    441544 ENDO STITCH 10MM NONE KOG COVIDIEN 173016 J4C1544X

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR