BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGASURE ATLAS HANDSWITCHING 37CM

    MDR report key: 1935694 · Received December 16, 2010

    Report

    Report Number
    3006451981-2010-00112
    Event Type
    Malfunction
    Date Received
    December 16, 2010
    Date of Event
    November 29, 2010
    Report Date
    December 5, 2010
    Manufacturer
    COVIDIEN LLC (SHANGHAI)
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE RETURN OF THE INCIDENT SAMPLE HAS BEEN REQUESTED. TO DATE IT HAS NOT BEEN REC'D FOR EVAL. ADDITIONAL QUESTIONS IN REGARD TO THE INCIDENT HAVE ALSO BEEN ASKED. IF THE SAMPLE IS REC'D OR IF ADDITIONAL INFO PERTINENT TO THE INCIDENT IS OBTAINED, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE HAND PIECE WAS CONNECTED TO A FORCETRIAD WHEN THE SURGEON CLOSED THE DEVICE ON THE TISSUE, ACTIVATED IT AND GOT AN END TONE, INDICATING A COMPLETED SEAL CYCLE. HOWEVER, THE SEAL WAS NOT COMPLETE AND WAS BLEEDING. THE SURGEON OPENED A SECOND DEVICE FROM THE SAME LOT # AND THE SAME THING HAPPENED. THE SURGEON THEN OPENED A THIRD DEVICE FROM ANOTHER LOT # AND IT SEALED PROPERLY. ONE DEVICE IS OPENED ON THE CURRENT MFR REPORT AND THE OTHER ON MFR REPORT # 1717344-210-00969. THERE WAS NO PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGASURE ATLAS HANDSWITCHING 37CM LIGASURE VESSEL SEALING SYSTEM GEI COVIDIEN LLC (SHANGHAI) S0D0036

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK FORCETRIAD - ENERGY PLATFORM, SN UNK