BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THUNDERBEAT 5MM 20CM INLINE GRIP

    MDR report key: 4003136 · Received June 26, 2014

    Report

    Report Number
    8010047-2014-00366
    Event Type
    Malfunction
    Date Received
    June 26, 2014
    Date of Event
    May 19, 2014
    Report Date
    June 4, 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

    AS A RESULT OF THE EVAL OF OLYMPUS MEDICAL SYSTEMS CORP (OMSC) ON (B)(4) 2014, IT WAS FOUND THAT THE PTFE PAD OF THE SUBJECT DEVICE WAS PARTIALLY SEPARATED. THERE WAS NO PATIENT INJURY REPORTED. THE SUBJECT DEVICE WAS RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP (OMSC) FOR EVALUATION. THE EVALUATION CONFIRMED THAT THE PTFE PAD PARTIALLY SEPARATED FROM THE JAW. THE MANUFACTURING RECORD WAS REVIEWED WITH NO IRREGULARITIES. BASED ON SIMILAR CASES WITH THE SAME MODEL, IT IS KNOWN THAT BY CONTINUOUSLY ACTIVATING OUTPUT WITHOUT GRASPING ANYTHING IN THE GRASPING SECTION (INCLUDING AFTER THE TISSUE SEPARATED), THE PTFE PAD SEVERELY WEARS, AND THE PAD WAS SEPARATED FROM THE GRASPING SECTION. CONSIDERING THE EVALUATION RESULT OF THE SUBJECT DEVICE, OMSC CONCLUDED THAT THE REPORTED EVENT OCCURRED SINCE THE USER CONTINUED ACTIVATING OUT PUT 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

    DURING USE OF THE SUBJECT DEVICE FOR A PANCREATICODUODENECTOMY, PROBE DAMAGE ERROR OCCURRED. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    373001 THUNDERBEAT 5MM 20CM INLINE GRIP THUNDERBEAT HANDPIECE GEI OLYMPUS MEDICAL SYSTEMS CORPORATION TB-0520IC 3XK

    Patients

    Seq Age Sex Outcome Treatment
    1