BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THUNDERBEAT 5MM, 35CM FRONT ACTUATED GRIP

    MDR report key: 4250438 · Received November 7, 2014

    Report

    Report Number
    8010047-2014-00672
    Event Type
    Malfunction
    Date Received
    November 7, 2014
    Date of Event
    October 14, 2014
    Report Date
    October 15, 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 DEVICE WAS RETURNED TO OLYMPUS MED SYSTEMS CORP (OMSC) FOR EVALUATION. THE EVALUATION CONFIRMED THAT THE PTFE PAD WAS PARTIALLY LIFTED FROM THE 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 IS SEVERELY WORN, AND THE DISTAL END OF THE PAD IS SEPARATED 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.

    Description of Event or Problem · 1

    THE SUBJECT DEVICE WAS USED DURING A LAPAROSCOPIC COLECTOMY. AFTER TWO TIMES OUTPUT, THE PTFE PAD OF THE DEVICE WAS SEPARATED. THE PROCEDURE WAS COMPLETED WITH A SIMILAR DEVICE. THERE WAS NO PT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    719444 THUNDERBEAT 5MM, 35CM FRONT ACTUATED GRIP THUNDERBEAT HANDPIECE GEI OLYMPUS MEDICAL SYSTEMS CORPORATION TB-0535FC K4623

    Patients

    Seq Age Sex Outcome Treatment
    1