BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN ENDO STITCH INSTRUMENT

    MDR report key: 1910204 · Received November 22, 2010

    Report

    Report Number
    1219930-2010-00889
    Event Type
    Injury
    Date Received
    November 22, 2010
    Report Date
    October 25, 2010
    Manufacturer
    UNITED STATES SURGICAL
    Product Code
    KOG
    PMA / PMN Number
    K934738
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ACCORDING TO THE RPTR: THE NEEDLE BROKE OFF FROM THE SUTURING DEVICE, AND THE NEEDLE PIECE COULD BE SEEN ON X-RAY, BUT THE SURGEON WAS UNABLE TO RETRIEVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN ENDO STITCH INSTRUMENT DISPOSABLE SUTURING DEVICE KOG UNITED STATES SURGICAL N9G0750

    Patients

    Seq Age Sex Outcome Treatment
    1 Other