BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRASONIC DISSECTOR

    MDR report key: 3924834 · Received June 23, 2014

    Report

    Report Number
    1717344-2014-00536
    Event Type
    Malfunction
    Date Received
    June 23, 2014
    Date of Event
    June 19, 2014
    Report Date
    June 20, 2014
    Manufacturer
    COVIDIEN LP
    Product Code
    LFL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE INCIDENT SAMPLE HAS BEEN REQUESTED BUT TO DATE 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 DURING A LAPAROSCOPIC EXCISION OF A LESION ON THE UTERUS, AN ERROR TONE WAS PROVIDED BY THE SYSTEM. THE DEVICE WAS REMOVED FROM THE PATIENT CAVITY AND WHEN THE ACTIVE WAVEGUIDE WAS TOUCHED BY THE SURGEON, A PIECE OF THE WAVEGUIDE DISENGAGED. NOTHING FELL INTO THE PATIENT CAVITY. A NEW DISSECTOR WAS OPENED AND USED TO SUCCESSFULLY COMPLETE THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    364823 ULTRASONIC DISSECTOR ULTRASONIC DISSECTOR LFL COVIDIEN LP UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK ULTRASONIC REUSABLE GENERATOR, SN UNK| ULTRASONIC REUSABLE BATTERY PACK, SN UNK