BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRASONIC DISSECTOR QTY OF 6

    MDR report key: 3170806 · Received May 22, 2013

    Report

    Report Number
    1717344-2013-00376
    Event Type
    Malfunction
    Date Received
    May 22, 2013
    Report Date
    April 29, 2013
    Manufacturer
    COVIDIEN LP
    Product Code
    LFL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE INCIDENT DEVICE HAS BEEN RECEIVED AND IS UNDER EVAL. WHEN THE DEVICE EVAL IS COMPLETE, A F/U REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE CUSTOMER ORIGINALLY REPORTED THAT THE DEVICE STOPPED WORKING AFTER 15 MINUTES OF USAGE. THERE WAS NO REPORTED PT INJURY OR BLOOD LOSS. THE DEVICE WAS RETURNED WITH A PIECE OF THE WAVEGUIDE DISENGAGED. THE CUSTOMER REPORTED THAT NOTHING FELL INTO THE PT CAVITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    226417 ULTRASONIC DISSECTOR QTY OF 6 ULTRASONIC DISSECTOR LFL COVIDIEN LP 239981X

    Patients

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