BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THUNDERBEAT 5MM 20CM INLINE GRIP

    MDR report key: 3961079 · Received May 26, 2014

    Report

    Report Number
    8010047-2014-00257
    Event Type
    Malfunction
    Date Received
    May 26, 2014
    Date of Event
    April 28, 2014
    Report Date
    May 1, 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 9.5 MM FROM THE DISTAL END. THE SHAPE OF THE FRACTURE SURFACE SHOWED THAT THE FRACTURE DEVELOPED FROM THE SCRATCHED AS THE STARTING POINT. THERE WERE CONTACT MARKS OF THE PROBE AND JAW WHERE THE PROBE WAS BROKEN 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. THIS REPORT IS BEING SUBMITTED AS A MEDICAL DEVICE REPORT IN AN ABUNDANCE OF CAUTION.

    Description of Event or Problem · 1

    DURING AN OPEN TOTAL CYSTECTOMY, THE PROBE TIP OF THE SUBJECT DEVICE WAS BROKEN AND FELL OFF INSIDE THE PATIENT. THE SURGEON REMOVED THE BROKEN PIECE. THE PROCEDURE WAS COMPLETED WITH A SIMILAR DEVICE. THERE WAS NO PATIENT HARM REPORTED WITHOUT THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310088 THUNDERBEAT 5MM 20CM INLINE GRIP THUNDERBEAT HANDPIECE GEI OLYMPUS MEDICAL SYSTEMS CORPORATION TB-0520IC K4124

    Patients

    Seq Age Sex Outcome Treatment
    1