BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THUNDERBEAT 5MM 35CM FRONT-ACTUATED GRIP

    MDR report key: 3982658 · Received June 16, 2014

    Report

    Report Number
    8010047-2014-00357
    Event Type
    Malfunction
    Date Received
    June 16, 2014
    Date of Event
    May 20, 2014
    Report Date
    May 20, 2014
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORPORATION
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUBJECT DEVICE IN THIS REPORT HAS NOT YET BEEN RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP (OMSC) FOR EVAL. THIS WILL BE SUPPLEMENTAL IF DEVICE EVAL BECOMES AVAILABLE.

    Description of Event or Problem · 1

    DURING USE OF THE SUBJECT DEVICE FOR AN UNCERTAIN PROCEDURE, SEVERAL SHORT CIRCUIT ERROR MESSAGES WERE DISPLAYED. THE PROCEDURE WAS COMPLETED WITH THE DEVICE, BUT THE PTFE PAD OF THE DEVICE WAS PARTIALLY SEPARATED FROM JAW AT THE END OF PROCEDURE. THERE WAS NO PT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    353438 THUNDERBEAT 5MM 35CM FRONT-ACTUATED GRIP THUNDERBEAT HANDPIECE GEI OLYMPUS MEDICAL SYSTEMS CORPORATION TB-0535FC 42K

    Patients

    Seq Age Sex Outcome Treatment
    1