BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MULTIFIRE ENDO TA 30-2.5 12MM STAPLER

    MDR report key: 3874822 · Received May 30, 2014

    Report

    Report Number
    2647580-2014-00435
    Event Type
    Injury
    Date Received
    May 30, 2014
    Date of Event
    May 20, 2014
    Report Date
    May 20, 2014
    Manufacturer
    COVIDIEN, FORMERLY USSC PUERTO RICO, INC.
    Product Code
    GDW
    PMA / PMN Number
    K910192
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE TYPE: LAPAROSCOPIC DONOR NEPHRECTOMY. ACCORDING TO THE REPORTER: THE SURGEON TRIED TO FIRE THE TA, HE CLAMPED DOWN AND THE PRODUCT WOULD NOT FIRE. IT SHORTENED AND BRUISED THE ARTERY MAKING IT MORE DIFFICULT TO COMPLETE THE ANASTOMOSIS IN THE RECIPIENT. THE HANDLE WAS SQUEEZED TO FIRE. NO STAPLES WERE DEPLOYED AFTER FIRING THE INSTRUMENT. ANOTHER TA WAS OPENED TO CUT THE ARTERY. THE ARTERY WAS ALREADY CLAMPED DOWN ON DURING FIRST ATTEMPTED FIRING-THEY HAD TO FIRE AT A MORE SUPERIOR LEVEL. THE CLAMPING DURING THE FIRST ATTEMPT BRUISED THE ARTERY. PATIENT IS IN RECOVERY AND DOING OKAY. NO REINFORCEMENT MATERIAL WAS USED. THERE WAS NO BLEEDING REPORTED IN EXCESS OF 500CC. THE CAUSE WAS NOT EXTENDED BY MORE THAN 30 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    319597 MULTIFIRE ENDO TA 30-2.5 12MM STAPLER DISPOSABLE SURGICAL STAPLING DEVICE GDW COVIDIEN, FORMERLY USSC PUERTO RICO, INC. P4B0291X

    Patients

    Seq Age Sex Outcome Treatment
    1 Other