BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THUNDERBEAT 5MM, 35CM, FRONT-ACTUATED GRIP

    MDR report key: 3815225 · Received April 24, 2014

    Report

    Report Number
    8010047-2014-00205
    Event Type
    Malfunction
    Date Received
    April 24, 2014
    Date of Event
    April 3, 2014
    Report Date
    April 9, 2014
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    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 THA THE PROBE BROKE DOWN AT 10MM FROM THE DISTAL END. THERE WAS A SCRATCH AT THE BROKEN POINT. THE SHAPE OF THE FRACTURE SURFACE SHOWED THA THE FRACTURE DEVELOPED FROM THE SCRATCHED AS THE STARTING POINT. THERE WERE CONTACT MARKS OF THE PROBE AND JAW WHERE THE PROBE WAS BROKE OFF. THE MANUFACTURING HISTORY WAS REVIEWED, WITH NO IRREGULARITIES NOTED. AS THE RESULT OF EVALUATION, WE HAVE CONCLUDED THAT PTFE PAD WAS WORN BY CONTINUOUSLY ACTIVATING OUTPUT WITHOUT GRASPING ANYTHING. CONSEQUENTLY, THE PROBE AND JAW CAME INTO CONTACT, WHICH CAUSED SCRATCHES IN BOTH THE PROBE AND JAW. AFTER THAT, SINCE PHYSICIAN CONTINUED TO USE THE DEVICE, THE PROBE TIP BROKE.

    Description of Event or Problem · 1

    DURING USE OF SUBJECT DEVICE FOR AN UNCERTAIN PROCEDURE, THE ERROR WAS OCCURRED. THERE WAS NO PATIENT HARM REPORTED. THE RESULT OF THE EVALUATION IN OLYMPUS MEDICAL SYSTEMS CORPORATION, IT WAS FOUND THAT THE PROBE OF SUBJECT DEVICE WAS BROKEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    249536 THUNDERBEAT 5MM, 35CM, FRONT-ACTUATED GRIP THUNDERBEAT HANDPIECE GEI OLYMPUS MEDICAL SYSTEMS CORP. TB-0535FC K3X03

    Patients

    Seq Age Sex Outcome Treatment
    1