BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TYCO-AUTO SUTURE UNITED STATES SURGICAL

    MDR report key: 1760785 · Received July 13, 2010

    Report

    Report Number
    MW5016738
    Event Type
    Injury
    Date Received
    July 13, 2010
    Date of Event
    July 12, 2010
    Report Date
    July 13, 2010
    Manufacturer
    COVIDIEN PLC.
    Product Code
    GDO
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE MD FIRED THE BLADE TO THE STAPLER BUT NO STAPLES DISCHARGED AT THAT TIME. THE BLADE DID NOT CUT PROPERLY AND IT PUSHED THE TISSUE OUT FROM THE STAPLER. IT WAS ADDITIONALLY NOTED THAT 3 OF THE 45 BLUE ROTICULATOR RELOADS DID NOT OPEN. DATES OF USE: (B)(6) 2010 - (B)(6) 2010.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TYCO-AUTO SUTURE UNITED STATES SURGICAL ENDOSCOPIC STAPLER, ENDO GIA UNIVERSAL 12MM GDO COVIDIEN PLC. NOE0304

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Disability