BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGASURE IMPACT

    MDR report key: 3101708 · Received April 30, 2013

    Report

    Report Number
    3006451981-2013-00133
    Event Type
    Malfunction
    Date Received
    April 30, 2013
    Date of Event
    March 25, 2013
    Report Date
    April 10, 2013
    Manufacturer
    COVIDIEN LLC (SHANGHAI)
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE INCIDENT DEVICE HAS BEEN RECEIVED AND IS UNDER EVALUATION. WHEN THE DEVICE EVALUATION IS COMPLETE A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE CUSTOMER ORIGINALLY REPORTED THAT THE DEVICE CUTTING PERFORMANCE WAS POOR FROM THE COMMENCEMENT OF A UROLOGICAL PROCEDURE BEING PERFORMED. THE SURGEON OPENED ANOTHER INSTRUMENT TO CONTINUE THE PROCEDURE. THE DEVICE WAS RETURNED WITH A MISSING HOOK ON THE SPINDLE CAP. THE CUSTOMER CONFIRMED THAT NOTHING FELL INTO THE PT CAVITY AND THAT THERE WAS NO PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    188043 LIGASURE IMPACT LIGASURE VESSEL SEALING SYSTEM GEI COVIDIEN LLC (SHANGHAI) S2JF018X

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK