BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGASURE ATLAS HANDSWITCHING 37CM

    MDR report key: 2891035 · Received November 9, 2012

    Report

    Report Number
    3006451981-2012-00204
    Event Type
    Malfunction
    Date Received
    November 9, 2012
    Report Date
    October 19, 2012
    Manufacturer
    COVIDIEN (SHANGHAI)
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE HAS BEEN REQUESTED BUT TO DATE, THE INCIDENT SAMPLE HAS NOT BEEN RECEIVED FOR EVAL. IF THE SAMPLE IS RECEIVED OR IF ADD'L INFO PERTINENT TO THE INCIDENT IS OBTAINED A F/U REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE DEVICE JAWS WOULD NO LONGER OPEN WHILE THEY WERE ON A VESSEL. THE SITE INDICATED THAT NO FURTHER DETAILS WOULD BE AVAILABLE. THERE WAS NO INJURY TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGASURE ATLAS HANDSWITCHING 37CM LIGASURE VESSEL SEALING SYSTEM GEI COVIDIEN (SHANGHAI) S2B0015X

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK