BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SILS STITCH SUTURING DEVICE

    MDR report key: 2133261 · Received May 11, 2011

    Report

    Report Number
    1219930-2011-00367
    Event Type
    Malfunction
    Date Received
    May 11, 2011
    Date of Event
    April 6, 2011
    Report Date
    April 7, 2011
    Manufacturer
    UNITED STATES SURGICAL
    Product Code
    OCW
    PMA / PMN Number
    K090419
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE TYPE: SILS GASTRECTOMY. ACCORDING TO THE REPORTER: THE DEVICE LOADED PROPERLY, WAS INSERTED INTO THE CAVITY AND WHEN THE SURGEON WENT TO TOGGLE IT THE NEEDLE FELL OUT INTO THE CAVITY. THE SURGEON WAS ABLE TO RETRIEVE THE NEEDLE. AFTER REMOVING THE DEVICE, IT WAS NOTICED THE LOCKING MECHANISM WAS NOT WORKING, THE LEFT SIDE (UNLOCK BUTTON) KEPT POPPING UP. THE SURGEON HAND SEWED TO COMPLETE THE CASE. THE CASE WAS DELAYED 30 MINUTES. NO TISSUE DAMAGE OR BLEEDING REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SILS STITCH SUTURING DEVICE DISPOSABLE SUTURING DEVICE OCW UNITED STATES SURGICAL N1A0246U

    Patients

    Seq Age Sex Outcome Treatment
    1