BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THUNDERBEAT 5MM 20CM INLINE GRI

    MDR report key: 3969288 · Received May 2, 2014

    Report

    Report Number
    8010047-2014-00220
    Event Type
    Malfunction
    Date Received
    May 2, 2014
    Date of Event
    April 14, 2014
    Report Date
    April 14, 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 (OMSC) FOR EVALUATION. THE EVALUATION CONFIRMED THAT THE PTFE PAD PARTIALLY SEPARATED. THERE WERE CONTACT MARKS ON THE SURFACE OF THE PROBE AND JAW. 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, AND THE DISTAL END OF THE PAD SEPARATES 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. THE INSTRUCTION MANUAL OF THE SUBJECT DEVICE ALREADY STATES. PLEASE CROSS-REFERENCE THE FOLLOWING REPORTS 3010047-2014-00192.

    Description of Event or Problem · 1

    DURING A LIVER RESECTION, THE ERROR OCCURRED. THE PHYSICIAN CHECKED THE SUBJECT DEVICE, AND THEN THE PROBE TIP OF THE FIRST SUBJECT DEVICE FELL OFF OUTSIDE THE PATIENT. THE PHYSICIAN REPLACED WITH THE SECOND SUBJECT DEVICE. HOWEVER, DURING USE OF THE SECOND SUBJECT DEVICE, THE PTFE PAD OF THE SECOND SUBJECT DEVICE WAS SEPARATED FROM THE JAW. THE PHYSICIAN REPLACED WITH A SIMILAR DEVICE AND THE PROCEDURE WAS COMPLETED. THERE WAS NO PATIENT HARM REPORTED. THIS IS A REPORT REGARDING THE SECOND SUBJECT DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    264164 THUNDERBEAT 5MM 20CM INLINE GRI THUNDERBEAT HANDPIECE GEI OLYMPUS MEDICAL SYSTEMS CORPORATION TB-0520IC K3Z17

    Patients

    Seq Age Sex Outcome Treatment
    1