BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOPATH ETS FLEX ENDO ARTICULATING LINEAR CU

    MDR report key: 2760189 · Received May 31, 2007

    Report

    Report Number
    2760189
    Event Type
    Injury
    Date Received
    May 31, 2007
    Date of Event
    May 4, 2007
    Report Date
    May 14, 2007
    Manufacturer
    ETHICON ENDO-SURGERY
    Product Code
    GAG
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    GA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    STAPLER MISFIRED, IT CUT BUT DID NOT STAPLE THE RENAL ARTERY. ATTEMPTS WERE MAE TO MANAGE BLEEDING VIA ENDOSCOPE BUT WERE ABANDONED AND VASCULAR SURGEON DID OPEN REPAIR OF RENAL ARTERY. PT REQUIRED 23 UNITS OF BLOOD DURING THE REPAIR AND HAD SEVERAL PERIODS OF ASYSTOLE, BUT HE WAS SUCCESSFULLY RESUSCITATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOPATH ETS FLEX ENDO ARTICULATING LINEAR CU LINEAR CUTTER/STAPLER GAG ETHICON ENDO-SURGERY ETS FLEX45

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Life Threatening| R