BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGASURE ATLAS HANDSWITCHING 37CM

    MDR report key: 1982140 · Received January 14, 2011

    Report

    Report Number
    3006451981-2011-00024
    Event Type
    Malfunction
    Date Received
    January 14, 2011
    Date of Event
    October 22, 2010
    Report Date
    January 14, 2011
    Manufacturer
    COVIDIEN LLC (SHANGHI)
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    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 RECEIVED FOR EVALUATION. ADDITIONAL QUESTIONS IN REGARD TO THE INCIDENT HAVE ALSO BEEN ASKED. IF THE SAMPLE IS RECEIVED OR IF ADDITIONAL INFORMATION PERTINENT TO THE INCIDENT IS OBTAINED, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE DEVICE WAS NOT CUTTING OR SEALING PROPERLY ALTHOUGH THE GENERATOR IN USE PROVIDED AN END TONE, INDICATING A COMPLETED SEAL CYCLE. THE CUSTOMER REPORTED THAT THERE MAY NOT HAVE BEEN ENERGY DELIVERED TO THE AREA WHEN SEALING WAS ATTEMPTED. THE SURGEON USED ANOTHER DEVICE TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGASURE ATLAS HANDSWITCHING 37CM LIGASURE VESSEL SEALING SYSTEM GEI COVIDIEN LLC (SHANGHI) S0C0007

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK