BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDO STITCH 10MM SUTURING DEVICE

    MDR report key: 2231491 · Received July 22, 2011

    Report

    Report Number
    1219930-2011-00608
    Event Type
    Malfunction
    Date Received
    July 22, 2011
    Report Date
    June 28, 2011
    Manufacturer
    UNITED STATES SURGICAL
    Product Code
    KOG
    PMA / PMN Number
    K934738
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER: NO PT INJURY OCCURRED. THE BLACK KNOB CAME OFF THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDO STITCH 10MM SUTURING DEVICE DISPOSABLE SUTURING DEVICE KOG UNITED STATES SURGICAL N1C0241

    Patients

    Seq Age Sex Outcome Treatment
    1