BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRASONIC DISSECTOR QTY OF 6

    MDR report key: 3031292 · Received March 5, 2013

    Report

    Report Number
    1717344-2013-00163
    Event Type
    Malfunction
    Date Received
    March 5, 2013
    Date of Event
    February 27, 2013
    Report Date
    March 4, 2013
    Manufacturer
    COVIDIEN LP
    Product Code
    LFL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    RISK MANAGER

    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 INFO PERTINENT TO THE INCIDENT IS OBTAINED A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT DURING USE, THE DEVICE WAS ACTIVATING INTERMITTENTLY. THE ACTIVATIONS LIGHTS WERE ALTERNATING FROM RED TO GREEN. THE SURGEON STOPPED USING THE DEVICE AND WHILE TRYING TO TROUBLESHOOT THE ACTIVATION PROBLEMS, A PIECE OF THE ACTIVE WAVEGUIDE DISENGAGED IN THE SURGEON'S HAND. NOTHING FELL INTO THE PT CAVITY. THE SURGEON INSTALLED A NEW DISSECTOR ON THE SETUP AND SUCCESSFULLY COMPLETED THE PROCEDURE. THERE WAS NO PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    94732 ULTRASONIC DISSECTOR QTY OF 6 ULTRASONIC DISSECTION SYSTEM LFL COVIDIEN LP UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK