BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THUNDERBEAT 5MM, 35CM, FRONT-ACTUATED GRIP

    MDR report key: 3810186 · Received February 4, 2014

    Report

    Report Number
    8010047-2014-00026
    Event Type
    Malfunction
    Date Received
    February 4, 2014
    Date of Event
    January 14, 2014
    Report Date
    January 14, 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 OLYMPUS MEDICAL SYSTEMS CORP (OMSC) FOR EVAL. THE EVAL CONFIRMED THAT THE PROBE BROKE DOWN AT 8.5MM FROM THE DISTAL END. AND THERE WAS A SCRATCH AT THE BROKEN POINT. 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 THE RESULT OF EVAL, WE HAVE CONCLUDED THAT THE PROBE TIP PRESUMABLY WAS SCRATCHED BECAUSE THE PHYSICIAN ACTIVATED SEAL AND CUT MODE OUTPUT WHILE THE PROBE TIP WAS IN CONTACT WITH METAL SUCH AS A CLIP AND FORCEPS. THE SHORT CIRCUIT ERROR DISPLAYED DUE TO THE CONTACT WITH METALS. AFTER THAT, SINCE THE PHYSICIAN CONTINUED TO USE THE DEVICE, A CRACK OF THE PROBE WAS OCCURRED AND THE PROBE DAMAGE ERROR DISPLAYED. WHEN THE PHYSICIAN WITHDREW THE SUBJECT DEVICE AND THE PROBE CHECK FUNCTION PERFORMED, THE PROBE PRESUMABLY BROKE OFF DUE TO THE STRESS BY ULTRASONIC VIBRATION. THE INSTRUCTION MANUAL OF THUNDERBEAT MENTIONS WARNING AND CAUTION FOR POSSIBLE MISHANDLING MENTIONED ABOVE. THIS REPORT IS BEING SUBMITTED AS A MEDICAL DEVICE REPORT IN AN ABUNDANCE OF CAUTION.

    Description of Event or Problem · 1

    WHEN THE PHYSICIAN USED THE SUBJECT DEVICE AS A SECOND DEVICE DURING A LAPAROSCOPY-ASSISTED TOTAL GASTRECTOMY, SOME SHORT CIRCUIT ERRORS DISPLAYED REPEATEDLY FROM BEGINNING OF THE USE. THE PHYSICIAN CONTINUED TO USE THE DEVICE WITH THE REASSEMBLY AND CLEANING. AFTER 20 MINUTES, THE PROBE DAMAGE ERROR DISPLAYED. WHEN THE DEVICE WAS REASSEMBLED AND CLEANED AND THE PROBE CHECK FUNCTION PERFORMED, THE PROBE TIP BROKE OFF ON THE INSTRUMENT TABLE. THE DEVICE WAS REPLACED WITH A SIMILAR DEVICE AND THE PROCEDURE WAS COMPLETED. THERE WAS NO PT HARM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    73637 THUNDERBEAT 5MM, 35CM, FRONT-ACTUATED GRIP THUNDERBEAT HANDPIECE GEI OLYMPUS MEDICAL SYSTEMS CORPORATION TB-03535FC K3924

    Patients

    Seq Age Sex Outcome Treatment
    1