BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDO STITCH

    MDR report key: 11715640 · Received April 23, 2021

    Report

    Report Number
    11715640
    Event Type
    Malfunction
    Date Received
    April 23, 2021
    Date of Event
    February 22, 2021
    Report Date
    April 14, 2021
    Manufacturer
    COVIDIEN LP
    Product Code
    OCW
    UDI-DI
    10884521100008
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    DURING DUODENAL SWITCH SURGICAL CASE, THE SURGEON REMOVED THE ENDO STITCH ENDOSCOPIC SUTURING UNIT FROM THE PATIENT AND HANDED IT OFF TO THE SCRUB TECH. WHEN THE SCRUB TECH ATTEMPTED TO REMOVE THE NEEDLE FROM THE ENDO STITCH DEVICE, HALF OF THE NEEDLE BROKE OFF AND THE OTHER HALF REMAINED IN THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    608804 ENDO STITCH ENDOSCOPIC TISSUE APPROXIMATION DEVICE OCW COVIDIEN LP 173016 10884521100008

    Patients

    Seq Age Sex Outcome Treatment
    1 17520 DA