BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROXIMATE ACCESS 55 ARTICULATING LINEAR STAPLER

    MDR report key: 2142692 · Received December 19, 2007

    Report

    Report Number
    2142692
    Event Type
    Injury
    Date Received
    December 19, 2007
    Date of Event
    December 9, 2007
    Report Date
    December 19, 2007
    Manufacturer
    ETHICON ENDO-SURGERY, INC.
    Product Code
    GDW
    Report Source
    User Facility report
    Reporter Location
    OH, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT RETURNED TO OPERATING ROOM FOR REPAIR OF PERFORATED ABDOMEN. GIA/LINEAR CUTTER (55) WAS USED. THE DEVICE CUT THE BOWEL BUT HAD NO STAPLES IN IT. A SECOND STAPLER HAD TO BE OBTAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROXIMATE ACCESS 55 ARTICULATING LINEAR STAPLER STAPLER GDW ETHICON ENDO-SURGERY, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization