BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THUNDERBEAT 5MM 10CM INLINE GRIP

    MDR report key: 3973268 · Received June 6, 2014

    Report

    Report Number
    8010047-2014-00318
    Event Type
    Malfunction
    Date Received
    June 6, 2014
    Date of Event
    May 26, 2014
    Report Date
    May 27, 2014
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORPORATION
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DURING USE OF THE SUBJECT DEVICE FOR A TOTAL GASTRECTOMY, THE PTFE PAD OF THE DEVICE WAS PARTIALLY SEPARATED AFTER ABOUT 15 MINUTES OF USE. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO PT INJURY REPORTED. THE SUBJECT DEVICE WAS RETURNED TO OLYMPUS MEDICAL SYSTEMS CORPORATION (OMSC) FOR EVAL. THE EVAL CONFIRMED THAT THE PTFE PAD PARTIALLY SEPARATED. THERE WERE CONTACT MARKS ON THE SURFACE OF THE PROBE AND JAW. THE MFG RECORD WAS REVIEWED WITH NO IRREGULARITIES. BASED ON THE 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 EVAL RESULT OF THE SUBJECT DEVICE, OMSC CONCLUDED THAT THE REPORTED EVENT OCCURRED SINCE THE USER CONTINUED ACTIVATING OUT PUT FOR AN EXTENDED TIME AFTER THE TISSUE ALREADY CUT. THE INSTRUCTION MANUAL OF THE SUBJECT DEVICE ALREADY STATES. THIS REPORT IS BEING SUBMITTED AS A MEDICAL DEVICE REPORT IN AN ABUNDANCE OF CAUTION.

    Description of Event or Problem · 1

    DURING A RIGHT LOBECTOMY, THE PTFE PAD OF THE SUBJECT DEVICE WAS PARTIALLY SEPARATED AFTER ABOUT 3 TIMES OUTPUT. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO PT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    331664 THUNDERBEAT 5MM 10CM INLINE GRIP THUNDERBEAT HANDPIECE GEI OLYMPUS MEDICAL SYSTEMS CORPORATION TB-0510IC K3Y18

    Patients

    Seq Age Sex Outcome Treatment
    1