BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDO GIA UNIVERSAL 12MM SINGLE USE INST

    MDR report key: 376597 · Received February 12, 2002

    Report

    Report Number
    1219930-2002-00005
    Event Type
    Injury
    Date Received
    February 12, 2002
    Report Date
    January 11, 2002
    Manufacturer
    NORTH HAVEN - USS
    Product Code
    GAG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    REPORTEDLY, THE INSTRUMENT MISFIRED, DID NOT FIRE PROPERLY. EXCESSIVE BLEEDING OCCURRED POST OP. RE-OPERATION OCCURRED THE SAME DAY, 13 UNITS OF BLOOD WERE NEEDED. THE STAPLE LINE WAS FINE, BUT BLEEDING STILL OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDO GIA UNIVERSAL 12MM SINGLE USE INST ENDOSCOPIC DISPOSABLE STAPLER GAG NORTH HAVEN - USS NA N1M301

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other