BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDO STITCH* 10MM SUTURING DEVICE

    MDR report key: 6125369 · Received November 23, 2016

    Report

    Report Number
    9612501-2016-00970
    Event Type
    Malfunction
    Date Received
    November 23, 2016
    Date of Event
    September 21, 2016
    Report Date
    October 27, 2016
    Manufacturer
    COVIDIEN
    Product Code
    KOG
    UDI-DI
    10884621100008
    PMA / PMN Number
    K934738
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER, DURING A SLEEVE GASTRECTOMY, THE DEVICE WAS VERY DIFFICULT TO LOAD, ONCE LOADED THE NEEDLE FELL OUT OF THE JAWS. A NEW DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY OR INVOLVEMENT WITH THE DEFECTIVE DEVICE. THERE WAS NO PATIENT INJURY OR HAZARD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    776675 ENDO STITCH* 10MM SUTURING DEVICE ENDOSCOPE AND/OR ACCESSORIES KOG COVIDIEN 173016 J6F2531X 10884621100008

    Patients

    Seq Age Sex Outcome Treatment
    1