BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THUNDERBEAT 5MM, 20CM INLINE GRIP

    MDR report key: 4250165 · Received November 5, 2014

    Report

    Report Number
    8010047-2014-00665
    Event Type
    Malfunction
    Date Received
    November 5, 2014
    Date of Event
    October 15, 2014
    Report Date
    October 16, 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 13 MM FROM THE DISTAL END. THE PTFE PAD WAS PARTIALLY LIFTED FROM THE JAW. THERE WERE CONTACT MARKS ON THE SURFACE OF THE PROBE AND THE JAW. THE SHAPE OF THE FRACTURE SURFACE SHOWED THAT THE FRACTURE DEVELOPED FROM THE SCRATCHED AS THE STARTING POINT. THE MANUFACTURING HISTORY WAS REVIEWED, WITH NO IRREGULARITIES NOTED. CONSIDERING THE EVALUATION RESULT OF THE SUBJECT DEVICE, OMSC CONCLUDED THAT THE REPORTED EVENT OCCURRED SINCE THE USER CONTINUED ACTIVATING OUTPUT FOR AN EXTENDED TIME AFTER THE TISSUE ALREADY CUT. 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 A HEPATECTOMY. THE PROBE WAS BROKEN AND FELL OFF INSIDE THE PATIENT. THE BROKEN TIP WAS RETRIEVED BY THE SURGEON. THE PROCEDURE WAS COMPLETED WITH A SIMILAR DEVICE. THERE WAS NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    710025 THUNDERBEAT 5MM, 20CM INLINE GRIP THUNDERBEAT HANDPIECE GEI OLYMPUS MEDICAL SYSTEMS CORPORATION TB-0520IC K4603

    Patients

    Seq Age Sex Outcome Treatment
    1