BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THUNDERBEAT 5 MM 35 CM FRONT-ACTUATED GRIP

    MDR report key: 3944325 · Received May 8, 2014

    Report

    Report Number
    8010047-2014-00228
    Event Type
    Malfunction
    Date Received
    May 8, 2014
    Date of Event
    April 17, 2014
    Report Date
    April 17, 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 CORP (OMSC) FOR EVALUATION. THE EVALUATION CONFIRMED THAT THE PTFE PAD PARTIALLY SEPARATED. THERE WERE CONTACT MARKS ON THE SURFACE OF THE PROBE AND THE GRASPING SECTION. 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 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. THIS REPORT IS BEING SUBMITTED AS A MEDICAL DEVICE REPORT IN AN ABUNDANCE OF CAUTION. PLEASE CROSS-REFERENCE THE FOLLOWING REPORTS: 8010047-2014-00229.

    Description of Event or Problem · 1

    DURING A LAPAROSCOPIC ASSISTED DISTAL GASTRECTOMY, THE ERROR OCCURRED. THEN THE PTFE PAD OF THE FIRST SUBJECT DEVICE WAS PARTIALLY SEPARATED. THE PHYSICIAN REPLACED WITH THE SECOND SUBJECT DEVICE; HOWEVER, THE PTFE PAD OF THE SUBJECT DEVICE WAS WORN AWAY. THE PROCEDURE WAS COMPLETED WITH A SIMILAR DEVICE. THERE WAS NO PATIENT HARM REPORTED. THIS IS A REPORT REGARDING THE FIRST SUBJECT DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    278155 THUNDERBEAT 5 MM 35 CM FRONT-ACTUATED GRIP THUNDERBEAT HANDPIECE GEI OLYMPUS MEDICAL SYSTEMS CORPORATION TB-0535FC K3X04

    Patients

    Seq Age Sex Outcome Treatment
    1