BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MULTIFIRE ENDO GIA 30-2.5 (V) 12MM STAPLER

    MDR report key: 3800311 · Received May 2, 2014

    Report

    Report Number
    2647580-2014-00328
    Event Type
    Injury
    Date Received
    May 2, 2014
    Date of Event
    April 7, 2014
    Report Date
    April 9, 2014
    Manufacturer
    COVIDIEN, FORMERLY USSC PUERTO RICO, INC.
    Product Code
    GDW
    PMA / PMN Number
    K900129
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE TYPE: DONOR NEPHRECTOMY. ACCORDING TO THE REPORTER: THE INSTRUMENT CUT WITHOUT STAPLING. ABOUT 100 CCS OF BLOOD LOSS. THEY USED ANOTHER STAPLER TO CORRECT THE PROBLEM. THERE WAS NO UNANTICIPATED TISSUE LOSS. THERE WAS NO TISSUE DAMAGE. THE CASE WAS NOT EXTENDED BY MORE THAN 30 MINUTES. NO BUTTRESS MATERIAL WAS USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    263953 MULTIFIRE ENDO GIA 30-2.5 (V) 12MM STAPLER DISPOABLE SURGICAL STAPLING DEVICE GDW COVIDIEN, FORMERLY USSC PUERTO RICO, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention