BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THUNDERBEAT 5MM 20 CM INLINE GRIP

    MDR report key: 4699140 · Received April 13, 2015

    Report

    Report Number
    8010047-2015-00301
    Event Type
    Malfunction
    Date Received
    April 13, 2015
    Date of Event
    March 24, 2015
    Report Date
    March 30, 2015
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORPORATION
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUBJECT DEVICE WAS RETURNED TO OMSC FOR EVALUATION. THE EVALUATION CONFIRMED THAT THE PTFE PAD WAS PARTIALLY PEELED FROM THE JAW. THERE WERE CONTACT MARKS ON THE SURFACE OF THE PROBE AND THE JAW. THE PROBE WAS CRACKED AT 13 MM FROM THE DISTAL END. THE MANUFACTURING RECORD WAS REVIEWED WITH NO IRREGULARITIES. CONSIDERING THE EVALUATION RESULT OF THE SUBJECT DEVICE, OMSC CONCLUDED THAT THE PTFE PAD PEELING OCCURED SINCE THE USER CONTINUED ACTIVATING OUTPUT WITHOUT CONTACT TISSUE (INCLUDING AFTER THE TISSUE ALREADY CUT) FOR AN EXTENDED TIME. AND OLYMPUS CONCLUDED THAT THE PROBE DAMAGE ERROR OCCURED SINCE THE PFE PAD WAS PEELED AND THE PROBE CONTACTED WITH THE JAW. 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 ABDOMINAL HEPATECTOMY. PROBE DAMAGE ERROR OCCURRED. THE PROCEDURE WAS COMPLETED BUT IT WAS NOT REPORTED DEVICE CHANGE. THERE WAS NO PATIENT INJURY REPORTED. BASED ON THE INVESTIGATION OF OLYMPUS, IT WAS FOUND THAT THE PTFE PAD OF THE DEVICE WAS SEPARATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    246480 THUNDERBEAT 5MM 20 CM INLINE GRIP THUNDERBEAT HANDPIECE GEI OLYMPUS MEDICAL SYSTEMS CORPORATION TB-0520IC K4515

    Patients

    Seq Age Sex Outcome Treatment
    1