BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THUNDERBEAT 5 MM, 35 CM, FRONT-ACTUATED GRIP

    MDR report key: 4071883 · Received August 12, 2014

    Report

    Report Number
    2951238-2014-00327
    Event Type
    Malfunction
    Date Received
    August 12, 2014
    Date of Event
    August 4, 2014
    Report Date
    August 4, 2014
    Manufacturer
    OLYMPUS MEDICAL SYSTEM CORPORATION
    Product Code
    GEI
    PMA / PMN Number
    K111202
    Removal / Correction Number
    Z-0432-14
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE REFERENCED IN THIS REPORT HAS NOT BEEN RETURNED TO OLYMPUS FOR EVALUATION. THE EXACT CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED AT THIS TIME. IF ADDITIONAL INFO OR IF THE DEVICE IS RECEIVED AT A LATER TIME THIS REPORT WILL BE SUPPLEMENTED.

    Description of Event or Problem · 1

    OLYMPUS WAS INFORMED THAT TOWARDS THE END OF A LOWER INTERIOR RESECTION PROCEDURE, A PROBE DAMAGE ERROR OCCURRED. THE PROBE TIP WAS VISUALLY INSPECTED AND A BUILD-UP OF TISSUE WAS NOTED. THE NURSE WIPED OFF THE TISSUE BUILD-UP WHEN THE PROBE TIP BROKE OFF. THERE WERE NO FRAGMENTS THAT FELL INSIDE THE PT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    478973 THUNDERBEAT 5 MM, 35 CM, FRONT-ACTUATED GRIP ULTRASONIC SURGICAL DEVICE GEI OLYMPUS MEDICAL SYSTEM CORPORATION TB-0535FC UNK

    Patients

    Seq Age Sex Outcome Treatment
    1