BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGASURE ATLAS HANDSWITCHING 37CM

    MDR report key: 3170834 · Received June 7, 2013

    Report

    Report Number
    3006451981-2013-00175
    Event Type
    Malfunction
    Date Received
    June 7, 2013
    Date of Event
    February 26, 2013
    Report Date
    May 16, 2013
    Manufacturer
    COVIDIEN LLC (SHANGHAI)
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). TO DATE THE INCIDENT SAMPLE HAS NOT BEEN RECEIVED FOR EVALUATION. 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 DURING A LEFT HEMICOLECTOMY, THE DEVICE WOULD NOT RE-OPEN AFTER THE SEAL CYCLE WAS COMPLETED. THE DEVICE WAS REPORTEDLY APPLIED TO A NORMAL AMOUNT OF TISSUE AT THE TIME. THE SURGEON USED A MONOPOLAR HOOK TO RESECT THE TISSUE IMMEDIATELY ADJACENT TO THE JAWS OF THE DEVICE IN ORDER TO REMOVE IT FROM THE TISSUE. THE MONOPOLAR HOOK AND ANOTHER COVIDIEN DEVICE WERE USED TO COMPLETE THE PROCEDURE WITHOUT FURTHER INCIDENT. THERE WAS NO PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    253750 LIGASURE ATLAS HANDSWITCHING 37CM LIGASURE VESSEL SEALING SYSTEM GEI COVIDIEN LLC (SHANGHAI) S2H0001X

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR UNKNOWN MONOPOLAR HOOK: LOT # UNK| COVIDIEN LS1020 LIGASURE ATLAS DEVICE: LOT # UNK