BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THUNDERBEAT 5MM 35CM FRONT-ACTUATED GRIP

    MDR report key: 3815205 · Received April 24, 2014

    Report

    Report Number
    8010047-2014-00188
    Event Type
    Malfunction
    Date Received
    April 24, 2014
    Date of Event
    March 26, 2014
    Report Date
    March 28, 2014
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    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 (OMSC) FOR EVALUATION. THE EVALUATION CONFIRMED THAT THE PTFE PAD PARTIALLY WORN AWAY. THERE WERE CONTACT MARKS ON THE SURFACE OF THE PROBE AND THE GRASPING SECTION. THE MANUFACTURING RECORD WAS REVIEWED WITH NO IRREGULARITIES. BASED ON THE 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. CONSIDER 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.

    Description of Event or Problem · 1

    DURING A LAPAROSCOPIC NEPHRECTOMY, THE SUBJECT DEVICE DID NOT WORK. THE RESULT OF THE EVALUATION IN OLYMPUS MEDICAL SYSTEMS CORPORATION (OMSC), IT WAS FOUND THAT THE PTFE PAD OF THE SUBJECT DEVICE WAS PARTIALLY WORN AWAY. THERE WAS NO PATIENT HARM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    249485 THUNDERBEAT 5MM 35CM FRONT-ACTUATED GRIP THUNDERBEAT HANDPIECE GEI OLYMPUS MEDICAL SYSTEMS CORP. TB-0535FC K3X04

    Patients

    Seq Age Sex Outcome Treatment
    1