BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGASURE ATLAS HANDSWITCHING 37CM

    MDR report key: 3221417 · Received June 28, 2013

    Report

    Report Number
    3006451981-2013-00202
    Event Type
    Malfunction
    Date Received
    June 28, 2013
    Date of Event
    March 6, 2013
    Report Date
    June 6, 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 EVAL. 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 HALF WAY THROUGH A PROCEDURE, THE DEVICE WOULD NOT REOPEN WHILE IT WAS APPLIED TO TISSUE. THE SURGEON RESECTED THE TISSUE DIRECTLY ADJACENT TO THE DEVICE IN ORDER TO REMOVE IT FROM THE TISSUE. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO INJURY TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    295622 LIGASURE ATLAS HANDSWITCHING 37CM LIGASURE VESSEL SEALING SYSTEM GEI COVIDIEN LLC (SHANGHAI) S2A0011X

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK