BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THUNDERBEAT 5MM 35CM PISTOL GRIP

    MDR report key: 3850757 · Received March 20, 2014

    Report

    Report Number
    8010047-2014-00118
    Event Type
    Malfunction
    Date Received
    March 20, 2014
    Date of Event
    January 28, 2014
    Report Date
    February 23, 2014
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORPORATION
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    PHYSICIAN

    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 14MM FROM THE DISTAL END. THE PIECE OF THE BROKEN PROBE WAS NOT RETURNED. THERE WAS A CONTACT MARK OF THE PROBE AND JAW WHERE THE PROBE WAS BROKEN OFF. THE PTFE PAD WAS WORN. THE MANUFACTURING HISTORY WAS REVIEWED, WITH NO IRREGULARITIES NOTED. BASED ON THE ANALYSIS RESULT ABOVE, IT IS HIGHLY LIKELY THAT SINCE THE DEVICE WAS GRASPING A THICK AND HARD TISSUE AND ACTIVATE WHILE TWISTING THE TISSUE, THE PTFE PAD UNEVENLY WORN AND THE PROBE AND JAW CAME INTO CONTACT WITH EACH OTHER. THAT CAUSED THE DEVICE A SCRATCH OCCURRED. AFTER THAT, SINCE THE PHYSICIAN CONTINUED TO USE THE DEVICE, THE CRACK OCCURRED AND THE "PROBE OFF". THE INSTRUCTION MANUAL OF THUNDERBEAT SCISSORS MENTIONS WARNING AND CAUTION FOR POSSIBLE MISHANDLING MENTIONED ABOVE. BASED UPON THE FINDING OF THE EVALUATION, THIS REPORT APPEARS TO BE RELATED TO USER MISHANDLING. THIS REPORT IS BEING SUBMITTED AS A MEDICAL DEVICE REPORT IN AN ABUNDANCE OF CAUTION.

    Description of Event or Problem · 1

    OLYMPUS WAS REPORTED THAT A WARNING WAS DISPLAYED CLOSE TO THE END OF A THERAPEUTIC PARTIAL NEPHRECTOMY. THE PROBE BROKE. THE SUBJECT DEVICE WAS REPLACED WITH ANOTHER DEVICE AND THE PROCEDURE WAS COMPLETED. THERE WAS NO PATIENT HARM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    167585 THUNDERBEAT 5MM 35CM PISTOL GRIP THUNDERBEAT HANDPIECE GEI OLYMPUS MEDICAL SYSTEMS CORPORATION TB-0545FC K3X15

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR