BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDO STITCH 10MM SUTURING DEVICE

    MDR report key: 1933438 · Received December 3, 2010

    Report

    Report Number
    1219930-2010-00910
    Event Type
    Malfunction
    Date Received
    December 3, 2010
    Date of Event
    October 28, 2010
    Report Date
    November 4, 2010
    Manufacturer
    UNITED STATES SURGICAL
    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

    NEEDLE BROKE IN HALF. A 10 MM PIECE OF SUTURE NEEDLE WAS REMOVED FROM THE PT ABDOMEN. THERE WAS NO BLEEDING REPORTED IN EXCESS OF 250CC. THE CASE WAS NOT EXTENDED BY MORE THAN 30 MINUTES. THERE WAS NO UNANTICIPATED TISSUE LOSS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDO STITCH 10MM SUTURING DEVICE DISPOSABLE SUTURING DEVICE KOG UNITED STATES SURGICAL N8F263

    Patients

    Seq Age Sex Outcome Treatment
    1