BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDO STITCH* 10MM SUTURING DEVICE

    MDR report key: 6066339 · Received October 31, 2016

    Report

    Report Number
    9612501-2016-00846
    Event Type
    Malfunction
    Date Received
    October 31, 2016
    Date of Event
    October 11, 2016
    Report Date
    October 11, 2016
    Manufacturer
    COVIDIEN
    Product Code
    OCW
    PMA / PMN Number
    K934738
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER, THE NEEDLE FELL OFF OF THE DEVICE AND WAS UNABLE TO BE REMOVED FROM THE VAGINAL CUFF TISSUE. THERE IS NO KNOWN IMPACT TO THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT YET RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    719613 ENDO STITCH* 10MM SUTURING DEVICE ENDOSCOPIC TISSUE APPROXIMATION DEVICE OCW COVIDIEN 173016

    Patients

    Seq Age Sex Outcome Treatment
    1 VLOC 180 ESTITCH ABS 2 0 8 LP ((B)(6) 2016)