BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGASURE ATLAS HANDSWITCHING 37CM

    MDR report key: 2231326 · Received July 25, 2011

    Report

    Report Number
    3006451981-2011-00093
    Event Type
    Malfunction
    Date Received
    July 25, 2011
    Date of Event
    June 27, 2011
    Report Date
    June 28, 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 SAMPLE HAS BEEN RETURNED BUT 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 AFTER SEALING, THE JAWS WOULD NO LONGER OPEN. TISSUE WAS RESECTED AROUND THE DEVICE IN ORDER TO REMOVE IT. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE WITHOUT INCIDENT. THERE WAS NO BLEEDING AND NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGASURE ATLAS HANDSWITCHING 37CM LIGASURE VESSEL SEALING SYSTEM GEI COVIDIEN LLC (SHANGHAI) S0M0029

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK