BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THUNDERBEAT 5MM 35CM PISTOL GRIP

    MDR report key: 3850756 · Received March 20, 2014

    Report

    Report Number
    8010047-2014-00116
    Event Type
    Malfunction
    Date Received
    March 20, 2014
    Date of Event
    January 28, 2014
    Report Date
    February 23, 2014
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORPORATION
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUBJECT DEVICE WAS RETURNED TO OLYMPUS MEDICAL SYSTEMS CORPORATION FOR EVALUATION. THE EVALUATION CONFIRMED THAT THE PROBE WAS NOT BROKEN. THE PTFE PAD PARTIALLY SEPARATED. THERE WAS A CONTACT MARK OF THE PROBE AND JAW. THE MANUFACTURING HISTORY WAS REVIEWED, WITH NO IRREGULARITIES NOTED. BASED ON THE EVALUATION AND THE PAST CASES WITH THE SAME MODEL, IT IS KNOWN THAT BY CONTINUOUSLY ACTIVATING OUTPUT WITHOUT GRASPING ANYTHING IN THE GRASPING SECTION (INCLUDING AFTER THE TISSUE SEPARATED), THE PTFE PAD SEVERELY WEARS, AND THE DISTAL END OF THE PAD SEPARATES FROM THE GRASPING SECTION. IN THE COURSE OF SEPARATING, SINCE THE DISTAL END OF THE PTFE PAD WORE SEVERELY AND BECAME THIN, THE PROBE AND GRASPING SECTION BECAME CONTACTING EACH OTHER, AND THE SCRATCHES INDICATING THAT THE PROBE AND GRASPING SECTION WERE IN CONTACT WITH EACH OTHER WERE MADE. DUE TO THE CONTACT DURING ACTIVATING OUTPUT, THE ERROR DISPLAYED. NOTE THAT THE INSTRUCTION MANUAL PROHIBITS ACTIVATING OUTPUT WHILE GRASPING NOTHING IN THE GRASPING SECTION (INCLUDING AFTER THE TISSUE SEPARATED). THE DESCRIPTION IN THE INSTRUCTION MANUAL IS CITED BELOW. DO NOT ACTIVATE OUTPUT FOR AN EXTENDED PERIOD WHILE THE GRASPING SECTION IS CLOSED WITHOUT CONTACTING TISSUE. BASED UPON THE FINDING OF THE EVALUATION, THIS REPORT APPEARS TO BE RELATED TO USER HANDLING. THIS REPORT IS BEING SUBMITTED AS A MEDICAL DEVICE REPORT IN AN ABUNDANCE OF CAUTION.

    Description of Event or Problem · 1

    OLYMPUS WAS REPORTED THAT A WARNING WAS DISPLAYED CLOSE TO THE END OF A THERAPEUTIC PARTIAL NEPHRECTOMY. THE PROBE BROKE. THE SUBJECT DEVICE WAS REPLACED WITH ANOTHER DEVICE AND THE PROCEDURE WAS COMPLETED. THERE WAS NO PATIENT HARM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    166772 THUNDERBEAT 5MM 35CM PISTOL GRIP THUNDERBEAT HANDPIECE GEI OLYMPUS MEDICAL SYSTEMS CORPORATION TB-0535FC K3620

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR