BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGASURE ATLAS HANDSWITCHING 20CM

    MDR report key: 2123599 · Received June 10, 2011

    Report

    Report Number
    1717344-2011-00452
    Event Type
    Malfunction
    Date Received
    June 10, 2011
    Date of Event
    May 23, 2011
    Report Date
    May 30, 2011
    Manufacturer
    COVIDIEN LLC (SHANGHAI)
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SITE INDICATED THAT THE INCIDENT SAMPLE WAS DISCARDED. 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 DURING A SIGMOIDECTOMY, THE JAWS OF THE DEVICE COULD NO LONGER BE OPENED WHILE ON TISSUE. THE DEVICE WAS CUT OFF IN ORDER TO REMOVE IT. THE SURGEON OPENED ANOTHER DEVICE AND COMPLETED THE PROCEDURE WITH NO FURTHER DIFFICULTIES. THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGASURE ATLAS HANDSWITCHING 20CM LIGASURE VESSEL SEALING SYSTEM GEI COVIDIEN LLC (SHANGHAI) UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK