BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THUNDERBEAT 5MM 35CM FRONT-ACTUATED GRIP

    MDR report key: 4904553 · Received July 9, 2015

    Report

    Report Number
    8010047-2015-00606
    Event Type
    Malfunction
    Date Received
    July 9, 2015
    Date of Event
    June 22, 2015
    Report Date
    June 24, 2015
    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 OMSC FOR EVALUATION. THE EVALUATION CONFIRMED THAT THE PTFE PAD WAS WORN AND PARTIALLY SEPARATED. THE MANUFACTURING HISTORY WAS REVIEWED, WITH NO IRREGULARITIES NOTED. CONSIDERING THE EVALUATION RESULT OF THE DEVICE, OMSC CONCLUDED THAT THE PTFE PAD WAS WORN AND PARTIALLY SEPARATED DUE TO ACTIVATING OUTPUT OF THE DEVICE BY THE USER WITHOUT GRASPING ANYTHING (INCLUDING AFTER THE TISSUE SEPARATED) WHILE THE GRASPING SECTION IS CLOSED. THE INSTRUCTION MANUAL OF THE DEVICE ALREADY CAUTIONS; DO NOT ACTIVATE OUTPUT IN SEAL & CUT MODE WHILE THE GRASPING SECTION IS CLOSED WITHOUT CONTACTING TISSUE OR VESSEL, OR ENSURING THAT TISSUE IS TRANSECTED. OTHERWISE, A LOCAL INCREASE OF THE TEMPERATURE DUE TO A FRICTION BETWEEN THE PROBE TIP AND THE GRASPING SECTION MAY RESULT IN VARIOUS FORMS OF DAMAGE IN THE PROBE TIP AND/OR THE PTFE PAD, SUCH AS PREMATURE WEAR, BREAKAGE, DEFORMATION, AND/OR FALLING OFF INSIDE THE BODY CAVITY AND/OR PARTIAL SEPARATING. BASED UPON THE FINDING OF THE EVALUATION, THIS REPORT APPEARS TO BE RELATED TO USER HANDLING.

    Description of Event or Problem · 1

    OLYMPUS MEDICAL SYSTEMS CORP (OMSC) WAS INFORMED THAT DURING A LAPAROSCOPIC ASSISTED COLECTOMY (LAC), THE SUBJECT DEVICE WAS USED. IN ABOUT 1 HOUR OF THE PROCEDURE, THE PTFE PAD OF THE DEVICE WAS SEPARATED. THE PROCEDURE WAS COMPLETED WITH ANOTHER THUNDERBEAT. THERE WAS NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    447698 THUNDERBEAT 5MM 35CM FRONT-ACTUATED GRIP THUNDERBEAT HANDPIECE GEI OLYMPUS MEDICAL SYSTEMS CORP. TB-0535FC K5109

    Patients

    Seq Age Sex Outcome Treatment
    1