BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THUNDERBEAT 5MM 35CM FRONT-ACTUATED GRIP

    MDR report key: 4849732 · Received June 17, 2015

    Report

    Report Number
    8010047-2015-00557
    Event Type
    Malfunction
    Date Received
    June 17, 2015
    Date of Event
    May 5, 2015
    Report Date
    May 20, 2015
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUBJECT DEVICE IN THIS REPORT HAS NOT YET BEEN RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) FOR EVALUATION. THE MANUFACTURING RECORD WAS REVIEWED WITH NO IRREGULARITIES. THE EXACT CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED AT THIS TIME. BASED ON THE SIMILAR CASES WITH THE SAME MODEL, THERE IS A POSSIBILITY THAT THE PROBE BREAKAGE OCCURRED SINCE THE USER OUTPUT THE DEVICE WHEN THE PROBE CONTACTED WITH SOMETHING HARD OR CONTACTED WITH THE METAL PART OF THE JAW BECAUSE OF WEAR OF THE PTFE PAD. 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

    THE SUBJECT DEVICE WAS USED DURING AN UNCERTAIN PROCEDURE. THE PROBE TIP OF THE DEVICE WAS BROKEN AND THE PROBE FRAGMENT FELL OFF INSIDE THE PATIENT. THE FRAGMENT WAS RETRIEVED FROM THE PATIENT BODY. THE PROCEDURE WAS CONTINUED WITH A DIFFERENT DEVICE. THERE WAS NO PATIENT HARM REPORTED WITHOUT THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    393293 THUNDERBEAT 5MM 35CM FRONT-ACTUATED GRIP THUNDERBEAT HANDPIECE GEI OLYMPUS MEDICAL SYSTEMS CORP. TB-0535FC 4YK

    Patients

    Seq Age Sex Outcome Treatment
    1