BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THUNDERBEAT 5MM 35CM PISTOL GRIP

    MDR report key: 3931356 · Received April 4, 2014

    Report

    Report Number
    8010047-2014-00183
    Event Type
    Malfunction
    Date Received
    April 4, 2014
    Date of Event
    March 18, 2014
    Report Date
    March 18, 2014
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORPORATION
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUBJECT DEVICE WAS RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP (OMSC) FOR EVALUATION. THE EVALUATION CONFIRMED THAT THE PTFE PAD PARTIALLY SEPARATED. THERE WERE CONTACT MARKS ON THE SURFACE OF THE PROBE AND THE GRASPING SECTION. THE MANUFACTURING RECORD WAS REVIEWED WITH NO IRREGULARITIES. BASED ON SIMILAR 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. CONSIDERING THE EVALUATION RESULT OF THE SUBJECT DEVICE, OMSC CONCLUDED THAT THE REPORTED EVENT OCCURRED SINCE THE USER CONTINUED ACTIVATING OUTPUT FOR AN EXTENDED TIME AFTER THE TISSUE ALREADY CUT. THE INSTRUCTION MANUAL OF THE SUBJECT DEVICE ALREADY STATES: WARNINGS: DO NOT ACTIVATE OUTPUT FOR AN EXTENDED PERIOD WHILE THE GRASPING SECTION IS CLOSED WITHOUT CONTACTING TISSUE. THIS REPORT IS BEING SUBMITTED AS A MEDICAL DEVICE REPORT IN AN ABUNDANCE OF CAUTION.

    Description of Event or Problem · 1

    DURING A LAP COLECTOMY, THE PTFE PAD OF THE SUBJECT DEVICE WAS PARTIALLY SEPARATED WITHIN TEN MINUTES. THE PHYSICIAN REPLACED THE SUBJECT DEVICE WITH A SIMILAR DEVICE. THE PROCEDURE WAS COMPLETED. THERE WAS NO PATIENT HARM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    203747 THUNDERBEAT 5MM 35CM PISTOL GRIP THUNDERBEAT HANDPIECE GEI OLYMPUS MEDICAL SYSTEMS CORPORATION TB-0535PC K3731

    Patients

    Seq Age Sex Outcome Treatment
    1