BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRASONIC DISSECTOR

    MDR report key: 4102761 · Received September 19, 2014

    Report

    Report Number
    1717344-2014-00786
    Event Type
    Malfunction
    Date Received
    September 19, 2014
    Date of Event
    July 22, 2014
    Report Date
    August 25, 2014
    Manufacturer
    COVIDIEN LP, FORMERLY KNOW AS VALLEYLAB, A DIVISON
    Product Code
    LFL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE INCIDENT ULTRASONIC DISSECTOR WAS RETURNED FOR EVALUATION. VISUAL INSPECTION OF THE DISPOSABLE HAND PIECE REVEALED THAT THE DEVICE HAD BEEN USED AND THE STATIC PART OF THE JAW HAD BROKEN OFF. THE BROKEN PIECE WAS NOT RETURNED WITH THE REST OF DEVICE. THE REMAINING WAVEGUIDE WAS INSPECTED UNDER MAGNIFICATION TO IDENTIFY THE POINT OF INITIAL CONTACT AND FRACTURE. IT WAS CONCLUDED THAT THE TITANIUM WAVEGUIDE FRACTURED DURING USE AND EVENTUALLY BROKE OFF. THE TITANIUM WAVEGUIDE MAY HAVE COME IN CONTACT WITH A HARD METALLIC OBJECT SUCH AS HEMOSTAT OR RETRACTOR AS EVIDENCED BY THE BREAK POINT AND METALLIC SCRAPING. THE USER'S GUIDE FOR THIS SYSTEM WARNS: CONTACT BETWEEN THE ACTIVE BLADE AND OTHER METAL OBJECTS (HEMOSTATS, CLIPS, STAPLES, RETRACTORS, ETC.) MAY RESULT IN UNINTENDED DAMAGE TO TISSUE AND/OR DEVICE FAILURE.

    Additional Manufacturer Narrative · 1

    (B)(4). DATE OF INITIAL REPORT : 09/03/2014. DATE OF FOLLOW-UP REPORT : 09/19/2014.

    Description of Event or Problem · 1

    THE CUSTOMER ORIGINALLY REPORTED THAT THE DEVICE STOPPED WORKING AFTER ONE HOUR OF USE. A RED LIGHT WAS OBSERVED WHEN THE SYSTEM STOPPED WORKING. A NEW INSTRUMENT WAS OPENED AND USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICE WAS RETURNED FOR EVALUATION AND WAS FOUND TO HAVE A BROKEN PIECE MISSING FROM THE ACTIVE WAVEGUIDE. THE BROKEN PIECE WAS NOT RETURNED. ADDITIONAL QUESTIONS HAVE BEEN ASKED TO THE CUSTOMER.

    Description of Event or Problem · 1

    NEW INFORMATION: THE CUSTOMER HAS ADVISED COVIDIEN THAT BREAKAGE OF THE WAVEGUIDE COULD ONLY HAVE HAPPENED IN TRANSIT BETWEEN THE OPERATING THEATRE AND SLUICE ROOM OR WHILE PACKAGING IT FOR COLLECTION. HE ALSO ADVISED THAT IT DID NOT HAPPEN WHILE BEING USED IN THE PATIENT OR IN THE SURGICAL ENVIRONMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    584325 ULTRASONIC DISSECTOR ULTRASONIC DISSECTOR LFL COVIDIEN LP, FORMERLY KNOW AS VALLEYLAB, A DIVISON 40700209X

    Patients

    Seq Age Sex Outcome Treatment
    1 Other ULTRASONIC REUSABLE GENERATOR -SERIAL # UNK,| ULTRASONIC REUSABLE BATTERY PACK - SERIAL # UNK