BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MULTIFIRE ENDO TA 30-2.5 12MM STAPLER

    MDR report key: 2821355 · Received October 25, 2012

    Report

    Report Number
    2647580-2012-00680
    Event Type
    Injury
    Date Received
    October 25, 2012
    Date of Event
    October 11, 2012
    Report Date
    October 15, 2012
    Manufacturer
    COVIDIEN, FORMERLY USSC
    Product Code
    GDW
    PMA / PMN Number
    K910192
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE TYPE: LIVING DONOR RIGHT SIDE NEPHRECTOMY. ACCORDING TO THE REPORTER: THE INSTRUMENT GOT STUCK ON THE ARTERY AND DID NOT STAPLE, NOR DID IT THE JAWS OPEN. THE SURGEON HAD TO CUT THE TISSUE LOOSE. A SECOND INSTRUMENT WAS OPENED AND THE JAWS BUT DID NOT CLOSE AGAIN AND WAS THEREFORE NEVER USED INSIDE THE PATIENT. A THIRD INSTRUMENT WAS USED AND WORKED PROPERLY. THE PATIENT HAD A FULL RECOVERY. THERE WAS NO BLOOD LOSS OF MORE THAN 250 CC, AND NO EXTENSION OF SURGERY TIME BY MORE THAN 30 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MULTIFIRE ENDO TA 30-2.5 12MM STAPLER DISPOSABLE SURGICAL STAPLER GDW COVIDIEN, FORMERLY USSC P2F0236X

    Patients

    Seq Age Sex Outcome Treatment
    1 Other