BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THUNDERBEAT 5MM 35CM PISTOL GRIP

    MDR report key: 3850758 · Received March 20, 2014

    Report

    Report Number
    8010047-2014-00137
    Event Type
    Malfunction
    Date Received
    March 20, 2014
    Date of Event
    February 21, 2014
    Report Date
    February 24, 2014
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORPORATION
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVALUATION CONFIRMED THAT PART OF THE PTFE PAD WAS MISSING. 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. SINCE THE PHYSICIAN ACTIVATED OUTPUT WITH GRASPING THE SEPARATED PART OF THE PAD, OR THE SEPARATED PART WAS APPLIED STRESS, THE SEPARATED PART OF PAD WAS PRESUMABLY BROKEN AND FELL OFF. 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

    FOR THE LAPAROSCOPIC NEPHRECTOMY, THE SUBJECT DEVICE WAS USED FOR ALMOST 2 HOURS. AT THE END OF THE SURGERY, IT WAS NOTICED THAT A PART OF THE PTFE PAD WAS MISSING AND FELL INTO THE PATIENT'S ABDOMINAL CAVITY. THE PIECE WAS RETRIEVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED AND THERE WAS NO PATIENT HARM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    167177 THUNDERBEAT 5MM 35CM PISTOL GRIP THUNDERBEAT HANDPIECE GEI OLYMPUS MEDICAL SYSTEMS CORPORATION TB-0535PC K3227

    Patients

    Seq Age Sex Outcome Treatment
    1