BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDO STITCH 10MM SUTURING DEVICE

    MDR report key: 2010164 · Received March 1, 2011

    Report

    Report Number
    1219930-2011-00157
    Event Type
    Malfunction
    Date Received
    March 1, 2011
    Date of Event
    January 14, 2011
    Report Date
    February 1, 2011
    Manufacturer
    UNITED STATES SURGICAL
    Product Code
    KOG
    PMA / PMN Number
    K934738
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER: THE NEEDLE BROKE IN HALF WHILE THE SURGEON WAS USING THE DEVICE INSIDE THE PATIENT. COMPLETE NEEDLE WAS SECURED AND ACCOUNTED FOR. IT COULD NOT BE REPORTED IF BLEEDING OCCURRED OR IF THERE WAS A DELAY IN OPERATING ROOM TIME. THERE WAS NO TISSUE DAMAGE OR UNANTICIPATED TISSUE LOSS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDO STITCH 10MM SUTURING DEVICE DISPOSABLE SUTURING DEVICE KOG UNITED STATES SURGICAL N0L0381

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR