BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THUNDERBEAT

    MDR report key: 2854898 · Received November 26, 2012

    Report

    Report Number
    2854898
    Event Type
    Malfunction
    Date Received
    November 26, 2012
    Date of Event
    October 17, 2012
    Report Date
    November 24, 2012
    Manufacturer
    OLYMPUS
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    WHITE TEFLON BETWEEN THE HAND PIECE AND TIP BROKE OFF WHILE SCRUB WAS CLEANING THE TIPS. THE DEVICE MADE A NOISE INDICATING IT NEEDED TO BE CLEANED. THE SCRUB SAW THE BROKEN OFF PIECE AND KEPT IT. THE DEVICE HAS BEEN RETURNED TO THE MANUFACTURER. NO PATIENT HARM. WE ARE SEEING A TREND WITH THIS DEVICE AND ARE HAVING SIMILAR ISSUES WITH IT IN OTHER CASES. WE WERE ABLE TO SEE THE ERROR LOGS VISUALLY ON THE DEVICE. THERE DOES NOT SEEM TO BE ANY TYPE OF ALARM TO INDICATE THAT THE USER IS ENERGIZING THE DEVICE TO LONG IN THE ULTRASONIC MODE, WHICH IS WHEN THIS PROBLEM IS OCCURRING. WE ARE CURRENTLY TRIALING THIS DEVICE WITH THE INTENT ON PURCHASING; HOWEVER,THE DEVICE DOES NOT ALERT THE USER TO A OVER ENERGIZED OR METAL ON METAL USE. THE PROBLEM CAN HAPPEN AT ANY POINT. TWO OF OUR DOCTORS SAID THEIR FEELING IS THAT IT KIND OF GOES WITH THE ULTRASONIC MODE THAT DAMAGE IS GOING TO OCCUR TO THE TIP WITH MORE OR PROLONGED USE OR ENERGIZING. WE NOTED THAT THE FDA WEBSITE HAS ABOUT 20-30 REPORTS RELATED TO THIS ISSUE FOR THIS DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 THUNDERBEAT ELECTROSURGICAL UNIT AND ACCESSORIES GEI OLYMPUS TB-0535PC 2JA030

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR