BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THUNDERBEAT 5MM, 35CM FRONT ACTUATED GRIP

    MDR report key: 4250150 · Received November 5, 2014

    Report

    Report Number
    8010047-2014-00671
    Event Type
    Malfunction
    Date Received
    November 5, 2014
    Date of Event
    September 17, 2014
    Report Date
    October 13, 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 MEDICAL SYSTEMS CORPORATION FOR EVALUATION. THE EVALUATION CONFIRMED THAT THE PROBE BROKE DOWN AT 1 MM FROM THE DISTAL END. THERE WAS A SCRATCH ON THE PROBE. THE SHAPE OF THE FRACTURE SURFACE SHOWED THAT THE FRACTURE DEVELOPED FROM THE SCRATCHED AS THE STARTING POINT. THE MANUFACTURING HISTORY WAS REVIEWED, WITH NO IRREGULARITIES NOTED. AS A RESULT OF THE DEVICE INVESTIGATION, OMSC CONCLUDED THAT THE REPORTED EVENT OCCURRED SINCE THE SURGEON OUTPUTTED THE DEVICE CONTACTING WITH SOMETHING HARD, AND THE PROBE CRACKED. AFTER THAT, THE PROBE WAS BROKEN WHEN THE USER CHECKED THE DEVICE OUTSIDE THE PATIENT BODY. 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

    THE SUBJECT DEVICE WAS USED DURING A LAPAROSCOPIC ASSISTED TOTAL GASTRECTOMY. PROBE DAMAGE ERROR MESSAGE WAS DISPLAYED. AFTER THAT, THE PROBE WAS BROKEN OFF WHEN THE SURGEON CHECKED THE PROBE OUTSIDE THE PATIENT BODY. THE PROCEDURE WAS COMPLETED WITH ANOTHER THUNDERBEAT DEVICE. THERE WAS NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    710023 THUNDERBEAT 5MM, 35CM FRONT ACTUATED GRIP THUNDERBEAT HANDPIECE GEI OLYMPUS MEDICAL SYSTEMS CORPORATION TB-0535FC K4501

    Patients

    Seq Age Sex Outcome Treatment
    1