BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROTACK 5MM INSTRUMENT

    MDR report key: 2150492 · Received June 22, 2011

    Report

    Report Number
    2647580-2011-00410
    Event Type
    Injury
    Date Received
    June 22, 2011
    Date of Event
    May 22, 2011
    Report Date
    May 22, 2011
    Manufacturer
    USSC PUERTO RICO
    Product Code
    GDW
    PMA / PMN Number
    K963999
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    DURING SURGERY, THE DR DISCOVERED THAT THE 6TH TACKER COULD NOT BE FIRED. THE 1ST TO 5TH TACKERS WERE FINE. SURGERY WAS EXTENDED FOR 60 MINUTES. PATIENT IS DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROTACK 5MM INSTRUMENT DISPOSABLE SURGICAL STAPLER GDW USSC PUERTO RICO P0G0661

    Patients

    Seq Age Sex Outcome Treatment
    1 Other