BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GIA UNIVERSAL

    MDR report key: 2974186 · Received February 12, 2013

    Report

    Report Number
    1219930-2013-00082
    Event Type
    Injury
    Date Received
    February 12, 2013
    Date of Event
    February 17, 2013
    Report Date
    February 4, 2013
    Manufacturer
    COVIDIEN, FORMERLY US SURGICAL
    Product Code
    GDW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE: ULTRA LOW ANTERIOR RESECTION WITH DIVERTING LOOP ILEOSTOMY, WEDGE RESECTION OF LIVER. ACCORDING TO THE REPORTER: NO OTHER INFORMATION ON PT. CUSTOMER REPORTS THAT THE STAPLER BROKE IN PIECES. SOME PIECES FELL ON FLOOR, AND ON PT. X-RAY WAS DONE WHILE PT WAS STILL IN THE OPERATING ROOM AND CLEARED. NO ILL-EFFECTS. PT CURRENT STATUS REPORTED AS RECOVERING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    62150 GIA UNIVERSAL DISPOSABLE STAPLER GDW COVIDIEN, FORMERLY US SURGICAL N2K0191X

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention