BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THUNDERBEAT 5 MM, 35 CM, FRONT-ACTUATED GRIP

    MDR report key: 19900921 · Received August 2, 2024

    Report

    Report Number
    9614641-2024-01566
    Event Type
    Malfunction
    Date Received
    August 2, 2024
    Date of Event
    July 9, 2024
    Report Date
    September 18, 2024
    Manufacturer
    AOMORI OLYMPUS CO., LTD.
    Product Code
    GEI
    PMA / PMN Number
    K111202
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE EVALUATION OF THE EVENT IS ONGOING. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE THE RESULTS OF THE LEGAL MANUFACTURER'S FINAL INVESTIGATION. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO DEVIATIONS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. THE DEVICE WAS RETURNED TO OLYMPUS FOR INSPECTION, AND THE CUSTOMER'S REPORTABLE MALFUNCTION WAS CONFIRMED. BASED ON THE RESULTS OF THE INVESTIGATION, IT IS LIKELY THAT THE SEAL & CUT OUTPUT WITH THE GRASPING PART CLOSED WITHOUT GRASPING THE TISSUE, WHICH CAUSED SEVERE WEAR OF THE TISSUE PAD. THE PROBE CAME INTO CONTACT WITH THE NON-INSULATING PART OF THE GRASPING PART DUE TO THE WORN TISSUE PAD. THE INSTRUCTIONS FOR USE WARNS THE PREVENTION METHOD ASSOCIATED WITH THE EVENT AS FOLLOWS: 1. 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 TISSUE PAD, SUCH AS PREMATURE WEAR, BREAKAGE, DEFORMATION, AND/OR FALLING OFF INSIDE THE BODY CAVITY AND/OR PARTIAL SEPARATING. 2. WHEN CUTTING AND VESSEL SEALING IS PERFORMED IN SEAL & CUT MODE, APPLY LIGHT TENSION ON THE TISSUE SO THAT USERS CAN CONFIRM IT IS TRANSECTED. ALSO, STOP ACTIVATION IMMEDIATELY AFTER TISSUE IS TRANSECTED. OTHERWISE, THE GRASPING SECTION, THE TISSUE PAD, OR THE PROBE TIP MAY BREAK AND FALL OFF, AND PARTIAL SEPARATING OF THE TISSUE PAD MAY OCCUR DUE TO A LOCAL INCREASE OF TEMPERATURE CAUSED BY THE FRICTION BETWEEN TISSUE PAD AND THE PROBE TIP DURING ACTIVATION. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED, THE SURGEON USED AN ULTRASONIC KNIFE TO COAGULATE AND CUT THE TISSUE, HOWEVER, THE ULTRASONIC SURGICAL DEVICE TISSUE PAD BROKE AND THE OPERATION COULD NOT CONTINUE. THE ISSUE OCCURRED DURING THORACOSCOPIC SEGMENTECTOMY THERAPEUTIC PROCEDURE FOR LUNG CANCER, AND THE PATIENT WAS UNDER GENERAL ANESTHESIA. THIS EVENT CAUSED A DELAY IN THE SURGERY TIME. THOUGH AN UNKNOWN DELAY WAS REPORTED, THE PROCEDURE WAS COMPLETED, AND THE DEVICE WAS IMMEDIATELY REPLACED. ALSO, THERE IS NO INDICATION WHERE THE DEVICE BROKE AND IF IT FELL INSIDE OF THE PATIENT. THERE WERE NO REPORTS OF PATIENT INJURY OR HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    384930 THUNDERBEAT 5 MM, 35 CM, FRONT-ACTUATED GRIP ULTRASONIC SURGICAL DEVICE GEI AOMORI OLYMPUS CO., LTD. TB-0535FC 39K

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown