BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGASURE ATLAS HANDSWITCHING 37CM

    MDR report key: 2981115 · Received February 4, 2013

    Report

    Report Number
    3006451981-2013-00021
    Event Type
    Malfunction
    Date Received
    February 4, 2013
    Date of Event
    January 10, 2013
    Report Date
    January 10, 2013
    Manufacturer
    COVIDIEN LLC (SHANGHAI)
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE HAS BEEN REQUESTED, 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 THERE WAS EVIDENCE OF THE PATIENT TISSUE TEARING WHILE THE DEVICE WAS CUTTING. THE CUSTOMER ALSO NOTED THAT THE JAWS OF THE DEVICE COULD NOT BE EASILY REMOVED AFTER SEALING THE TISSUE. THIS WAS THE SECOND DEVICE USED IN THE PROCEDURE (REFERENCE 3006451981-2013-00020 FOR THE FIRST DEVICE). THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    45970 LIGASURE ATLAS HANDSWITCHING 37CM LIGASURE VESSEL SEALING SYSTEM GEI COVIDIEN LLC (SHANGHAI) S1A0012

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK