BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TA PREMIUM 55 MEDIUM REUSABLE INSTRUMENT

    MDR report key: 1820722 · Received August 27, 2010

    Report

    Report Number
    2647580-2010-00731
    Event Type
    Injury
    Date Received
    August 27, 2010
    Report Date
    August 4, 2010
    Manufacturer
    USSC PUERTO RICO
    Product Code
    GDW
    PMA / PMN Number
    K801589
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER: THE INSTRUMENT TWISTED AND THE POSITIONING PIN PERFORATED THE COLON. A BAD STAPLE LINE WAS FORMED. THEY PERFORMED A STOMA ON THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TA PREMIUM 55 MEDIUM REUSABLE INSTRUMENT SURGICAL STAPLER GDW USSC PUERTO RICO 4456

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention TA PREMIUM, (B)(4), 55-3.5 TITANIUM DLU