BEUDAMED
    FDA Adverse Event Death Summary report: N

    GIA 80-3.8 SINGLE USE RELOADABLE STAPLER

    MDR report key: 1882442 · Received October 21, 2010

    Report

    Report Number
    2647580-2010-00842
    Event Type
    Death
    Date Received
    October 21, 2010
    Report Date
    September 24, 2010
    Manufacturer
    USSC PUERTO RICO
    Product Code
    GDW
    PMA / PMN Number
    K013860
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE TYPE: BOWEL SURGERY. PATIENT GENDER: UNKNOWN. ACCORDING TO THE REPORTER: AFTER THE SURGERY A POST-OP LEAK WAS NOTICED, AND THE PATIENT WAS RETURNED TO THE OPERATING ROOM. PATIENT EXPIRED. NO ADDITIONAL INFORMATION AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GIA 80-3.8 SINGLE USE RELOADABLE STAPLER DISPOSABLE SURGICAL STAPLER GDW USSC PUERTO RICO UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Death