BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THUNDERBEAT 5 MM, 35 CM, FRONT-ACTUATED GRIP TYPE S

    MDR report key: 16865746 · Received May 3, 2023

    Report

    Report Number
    9614641-2023-00607
    Event Type
    Malfunction
    Date Received
    May 3, 2023
    Date of Event
    April 4, 2023
    Report Date
    July 17, 2023
    Manufacturer
    AOMORI OLYMPUS CO., LTD.
    Product Code
    GEI
    UDI-DI
    04953170383557
    PMA / PMN Number
    K211838
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED TO OLYMPUS FOR EVALUATION BUT THE INVESTIGATION IS ONGOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE DEVICE EVALUATION AND THE LEGAL MANUFACTURER'S FINAL INVESTIGATION. CORRECTION TO H4, INFORMATION WAS INADVERTENTLY NOT INCLUDED ON THE INITIAL MEDWATCH. THE DEVICE WAS RETURNED AND AN EVALUATION WAS COMPLETED FOR IT. DURING INSPECTION, OLYMPUS CONFIRMED THE REPORTED EVENT, THE PROBE WAS BROKEN AROUND THE OUTER PIPE. THE PICTURE OF THE BROKEN SURFACE OF THE PROBE REVEALS THAT THE BREAKAGE STARTED AT THE CRACKED AREA OF THE PROBE. NO SCRATCHES OR CONTACT MARKS ON THE NON-INSULATED AREA OF THE GRASPING SECTION WERE CONFIRMED. ADDITIONALLY, THE COATING OF THE GRASPING SECTION WAS PARTIALLY PEELED OFF; HOWEVER, THIS DEFECT IS NOT CONSIDERED SEVERE ENOUGH TO CAUSE A POTENTIAL ADVERSE EVENT. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO DEVIATIONS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. ALTHOUGH A DEFINITIVE ROOT CAUSE CANNOT BE IDENTIFIED, THE FOLLOWING STEP-BY-STEP SCENARIO LIKELY CAUSED THE EVENT: 1) DURING THE OUTPUT ACTIVATION IN SEAL & CUT MODE, THE DISTAL END OF THE PROBE WAS SLIGHTLY CONTACTING A DEVICE WITH A THIN TIP, CAUSING SPARK GENERATION. 2) A FORCE WAS APPLIED TO THE PROBE DURING SPARK GENERATION. 3) A FORCE TO GRASP TISSUE OR A FORCE TO ACTIVATE THE OUTPUT IN SEAL & CUT MODE WAS APPLIED TO THE PROBE. THIS GENERATED CRACKS ON THE PROBE. 4) DUE TO CONTINUOUS USE OF THE DEVICE, THE CRACKS ON THE PROBE PROGRESSED. THIS LED TO BREAKAGE OF THE PROBE. THE FOLLOWING INFORMATION IS INCLUDED IN THE INSTRUCTIONS FOR USE (IFU): ¿DO NOT GRASP OR LET THE PROBE TIP CONTACT HARD OBJECTS SUCH AS METAL CLIPS, STAPLER, OR OTHER INSTRUMENTS (E.G., UTERINE MANIPULATOR). ALSO, BE CAREFUL TO AVOID CONTACTING THE PROBE TIP WITH THOSE ACCIDENTALLY. PARTICULARLY DURING ACTIVATION, A SCRATCH ON THE PROBE TIP COULD OCCUR DUE TO ULTRASONIC VIBRATION, WHICH LEADS THE PROBE TIP TO BREAK AND FALL OFF INTO THE BODY CAVITY. IN ADDITION, THE HIGH-FREQUENCY (RF BIPOLAR) CURRENT FLOWS THROUGH THE METAL AND GENERATES SPARK DISCHARGE, WHICH MAY CAUSE BURNS AND DECREASE FUNCTIONALITIES.¿ ¿IF THE GRASPING SECTION, METAL-EXPOSED AREA AROUND IT OR THE PROBE TIP GETS STICKED TISSUE DURING TREATMENT, WIPE IT WITH A SOFT OBJECT SUCH AS A PIECE OF GAUZE OR A BRUSH. DO NOT ATTEMPT TO SCRAPE IT WITH A SHARP OBJECT SUCH AS A SCALPEL OR THE TIP OF TWEEZERS. OTHERWISE, THE GRASPING SECTION, METAL-EXPOSED AREA AROUND IT, THE FLUORINE RESIN PART, A COATED SURFACE OR THE PROBE TIP MAY BE SCRATCHED AND DAMAGED, WHICH MAY LEAD TO FALL-OFF OF THE DAMAGED PART INTO THE BODY CAVITY OR BURNS OF THE TISSUE BY A HIGH-FREQUENCY LEAK CURRENT OUTPUT DUE TO DESTRUCTION OF THE INSULATION STRUCTURE.¿ OLYMPUS WILL CONTINUE TO MONITOR THE PERFORMANCE OF THIS DEVICE.

    Description of Event or Problem · 0

    A CUSTOMER REPORTED TO OLYMPUS, IN THE MIDDLE OF A THERAPEUTIC THORACIC PROCEDURE THE THUNDERBEAT SCISSOR BROKE WHILE CLEANING. THE PROCEDURE WAS COMPLETED USING A REPLACEMENT DEVICE. THERE WAS NO REPORT OF MEDICAL INTERVENTION BEING REQUIRED OR PATIENT HARM ASSOCIATED WITH THIS EVENT. USAGE OF SUBJECT DEVICE BEFORE EVENT: THE USG-400 (ULTRASONIC GENERATOR) SOFTWARE VERSION WAS 2.00. THE SETTING OF ITM (INTELLIGENT TISSUE MONITORING) ¿ON¿ WHEN THE THUNDERBEAT WAS USED. IN THE HOSPITAL, THE SETTING OF ITM IS USUALLY ¿ON¿ WHEN THE THUNDERBEAT WAS USED. THE USER UNDERSTOOD CHARACTERISTICS OF ITM FUNCTIONALITY. THE USER CHANGED THE ITM SETTING DURING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    859748 THUNDERBEAT 5 MM, 35 CM, FRONT-ACTUATED GRIP TYPE S ULTRASONIC SURGICAL DEVICE GEI AOMORI OLYMPUS CO., LTD. TB-0535FCS PW308428 04953170383557

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown