BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGASURE ATLAS HANDSWITCHING 37CM

    MDR report key: 2000132 · Received February 18, 2011

    Report

    Report Number
    3006451981-2011-00038
    Event Type
    Malfunction
    Date Received
    February 18, 2011
    Report Date
    February 8, 2011
    Manufacturer
    COVIDIEN LLP (SHANGHAI)
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE INCIDENT SAMPLE HAS BEEN REQUESTED BUT TO DATE HAS NOT BEEN RECEIVED FOR EVAL. IF THE SAMPLE IS RECEIVED 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 WHILE IN USE ON THE PT, THE DEVICE WORKED AS EXPECTED. HOWEVER, WHILE NOT IN USE, THE DEVICE ACTIVATED BY ITSELF. THERE WAS NO PT INJURY. THE SURGEON OPENED A SECOND DEVICE AND IT WORKED FINE. A FOOT PEDAL WAS IN USE AT THE TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGASURE ATLAS HANDSWITCHING 37CM LIGASURE VESSEL SEALING SYSTEM GEI COVIDIEN LLP (SHANGHAI) S0L0004

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK LIGASURE GENERATOR - (B)(4)