BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THUNDERBEAT 5 MM 35 CM FRONT-ACTUATED GRIP

    MDR report key: 3973243 · Received June 6, 2014

    Report

    Report Number
    8010047-2014-00307
    Event Type
    Malfunction
    Date Received
    June 6, 2014
    Date of Event
    May 15, 2014
    Report Date
    May 19, 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

    THE SUBJECT DEVICES WERE 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 JAW. 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. THIS REPORT IS BEING SUBMITTED AS A MEDICAL DEVICE REPORT IN AN ABUNDANCE OF CAUTION. PLEASE CROSS-REFERENCE 8010047-2014-00306, 8010047-2014-00308.

    Description of Event or Problem · 1

    DURING A LAPAROSCOPIC HEPATECTOMY, 3 SUBJECT DEVICES FAILED. THE PTFE PAD OF 3 SUBJECT DEVICE WAS PARTIALLY SEPARATED AFTER ABOUT 1 HOUR OF USE. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO PATIENT INJURY REPORTED. THIS IS A REPORT REGARDING THE SECOND SUBJECT DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    331422 THUNDERBEAT 5 MM 35 CM FRONT-ACTUATED GRIP THUNDERBEAT HANDPIECE GEI OLYMPUS MEDICAL SYSTEMS CORPORATION TB-0535FC K3X24

    Patients

    Seq Age Sex Outcome Treatment
    1