BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRASONIC DISSECTOR QTY OF 6

    MDR report key: 3192396 · Received June 18, 2013

    Report

    Report Number
    1717344-2013-00439
    Event Type
    Malfunction
    Date Received
    June 18, 2013
    Date of Event
    April 19, 2013
    Report Date
    May 24, 2013
    Manufacturer
    COVIDIEN LP
    Product Code
    LFL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE RETURN OF THE INCIDENT SAMPLE HAS BEEN REQUESTED. TO DATE IT HAS NOT BEEN RECEIVED FOR EVALUATION. ADDITIONAL QUESTIONS IN REGARD TO THE INCIDENT HAVE ALSO BEEN ASKED. 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 A PIECE OF THE ACTIVE WAVEGUIDE DISENGAGED FROM THE DISSECTOR DURING A PROCEDURE AND FELL INTO THE PATIENT CAVITY. THE PIECE WAS RETRIEVED FROM THE CAVITY. THERE WAS NO PATIENT INJURY. THE SURGEON INSTALLED ANOTHER DISSECTOR ONTO THE SYSTEM AND SUCCESSFULLY COMPLETED THE PROCEDURE. ADDITIONAL QUESTIONS HAVE BEEN ASKED. TO DATE, NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE TO COVIDIEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    277326 ULTRASONIC DISSECTOR QTY OF 6 ULTRASONIC DISSECTOR LFL COVIDIEN LP 235604X

    Patients

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