BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDO STITCH* 10MM SUTURING DEVICE

    MDR report key: 6182062 · Received December 16, 2016

    Report

    Report Number
    9612501-2016-01085
    Event Type
    Malfunction
    Date Received
    December 16, 2016
    Date of Event
    December 1, 2016
    Report Date
    December 1, 2016
    Manufacturer
    COVIDIEN
    Product Code
    OCW
    PMA / PMN Number
    K934738
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER, THE DEVICE WOULD NOT HOLD THE NEEDLE. THE RELOAD FELL OUT OF THE DEVICE FIVE TIMES. IT FELL INTO THE PATIENT AND WAS RETRIEVED. THE PROCEDURE WAS COMPLETED WITH THE SAME DEVICE. THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    830877 ENDO STITCH* 10MM SUTURING DEVICE ENDOSCOPIC TISSUE APPROXIMATION DEVICE OCW COVIDIEN 173016

    Patients

    Seq Age Sex Outcome Treatment
    1