BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDO STITCH* 10MM SUTURING DEVICE

    MDR report key: 6085912 · Received November 8, 2016

    Report

    Report Number
    9612501-2016-00874
    Event Type
    Malfunction
    Date Received
    November 8, 2016
    Date of Event
    October 10, 2016
    Report Date
    October 11, 2016
    Manufacturer
    COVIDIEN
    Product Code
    KOG
    PMA / PMN Number
    K934738
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER, DURING A LAP PARAESOPHAGEAL HERNIA PROCEDURE, THE NEEDLE FELL OUT OF INSTRUMENT. NO DEVICE FRAGMENT OR COMPONENT FELL INTO THE PATIENT'S CAVITY. THERE WAS NO PATIENT INJURY. THERE WAS NO UNANTICIPATED TISSUE LOSS. THERE WAS NO UNANTICIPATED BLOOD LOSS OF 500CC OR MORE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    737512 ENDO STITCH* 10MM SUTURING DEVICE ENDOSCOPE AND/OR ACCESSORIES KOG COVIDIEN 173016

    Patients

    Seq Age Sex Outcome Treatment
    1