BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THUNDERBEAT 5MM, 35CM FRONT-ACTUATED GRIP

    MDR report key: 4200942 · Received September 16, 2014

    Report

    Report Number
    8010047-2014-00539
    Event Type
    Malfunction
    Date Received
    September 16, 2014
    Date of Event
    August 20, 2012
    Report Date
    August 20, 2014
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORPORATION
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUBJECT DEVICE WAS RETURNED TO OMSC FOR EVALUATION. THE EVALUATION CONFIRMED THAT THE PTFE PAD ON THE GRASPING SECTION OF THE SUBJECT DEVICE WAS SEVERELY WORN AND THE METAL PART WAS EXPOSED. BOTH THE PROBE TIP AND THE GRASPING SECTION HAD CONTACT MARKS WITH EACH OTHER. 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), TH PTFE PAD SEVERELY WEARS. CONSIDERING THE EVALUATION RESULTS OF THE SUBJECT DEVICE, OMSC CONCLUDED THAT THE REPORTED EVENT OCCURRED SINCE THE USER ACTIVATED OUTPUT WITHOUT GRASPING ANYTHING THEN THE GRASPING SECTION WITH THE SEVERELY WORN PAD AND THE PROBE CONTACTED. 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

    OLYMPUS MEDICAL SYS CORP (OMSC) WAS INFORMED THAT DURING THE SAME LAPAROSCOPIC ASSISTED GASTRECTOMY (CANCER), THREE SETS OF TB-0535FC WERE USED. DURING THE USE WITH THE SUBJECT DEVICE THAT WAS THE ONE OF THEM, THE SEAL AND CUT SHORT CIRCUIT ERROR OCCURRED. AND THE PTFE PAD ON THE GRASPING SECTION OF THE SUBJECT DEVICE WAS SEVERELY WORN. OMSC WAS INFORMED THAT THE USER ACTIVATED OUTPUT WITHOUT GRASPING ANYTHING IN THE GRASPING SECTION. THERE WAS NO REPORT OF PT'S INJURY REGARDING THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    573092 THUNDERBEAT 5MM, 35CM FRONT-ACTUATED GRIP THUNDERBEAT HANDPIECE GEI OLYMPUS MEDICAL SYSTEMS CORPORATION TB-0535FC K3X10

    Patients

    Seq Age Sex Outcome Treatment
    1