BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THUNDERBEAT 5 MM, 20 CM, FRONT-ACTUATED GRIP TYPE S

    MDR report key: 17423968 · Received July 31, 2023

    Report

    Report Number
    9614641-2023-01054
    Event Type
    Injury
    Date Received
    July 31, 2023
    Date of Event
    July 5, 2023
    Report Date
    October 3, 2023
    Manufacturer
    AOMORI OLYMPUS CO., LTD.
    Product Code
    GEI
    UDI-DI
    04953170383571
    PMA / PMN Number
    K211838
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE LEGAL MANUFACTURER'S FINAL INVESTIGATION AND DEVICE EVALUATION WITH CORRECTION TO THE INITIAL WITH INFORMATION INADVERTENTLY LEFT OUT. THE DEVICE WAS RETURNED TO OLYMPUS FOR INSPECTION, AND THE CUSTOMER'S COMPLAINT/REPORTABLE MALFUNCTION WAS CONFIRMED. THE COMPLETE EVALUATION RESULTS ARE AS FOLLOWED: THE PROBE IS BROKEN AT 14,1MM FROM THE DISTAL END SITE. GASPING SECTION OF THE JAW WITH COATING PEELING OFF AND SCRATCHED. HYDROGEN ELECTRODE WITH COATING PEELING OFF. PROBE TIP WITH CONTACT MARK AND BROKEN/CRACKED. TISSUE PAD WITH MINOR DEFORMATION. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO DEVIATIONS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. BASED ON THE RESULTS OF THE INVESTIGATION, IT IS LIKELY THE PROBE BROKE AND HAD TO BE RETRIEVED OCCURRED DUE TO ONE OF THE FOLLOWING MECHANISMS: PROBE CONTACT WITH HARD TISSUE SUCH AS BONE OR CALCIFIED TISSUE, METAL CLIPS, STAPLES, OR OTHER SURGICAL INSTRUMENTS. DUE TO THE ULTRASONIC VIBRATION, COATING OF THE PROBE PEELED OFF. ALSO, IT CAUSED SCRATCHES ON THE PROBE. A FORCE TO ACTIVATE THE OUTPUT IN SEAL & CUT MODE OR A FORCE TO GRASP THE BODY TISSUE WAS APPLIED TO THE PROBE. THIS CAUSED CRACKS TO BRANCH OUT AT THE SCRATCHED AREA OF THE PROBE. A FORCE WAS APPLIED TO THE PROBE CAUSING IT TO BREAK. THE COATING OF THE GRASPING SECTION COULD HAVE COME OFF WHEN DIRT SUCH AS BURN WAS SCRAPED OFF WITH SOMETHING HARD. HOWEVER, THE ROOT CAUSE OF THE SUGGESTED EVENT COULD NOT BE IDENTIFIED. THE EVENT CAN BE PREVENTED BY FOLLOWING THE INSTRUCTIONS FOR USE WHICH STATE: THE THUNDERBEAT INSTRUMENT SHOULD BE USED FOR SOFT TISSUE. DO NOT ACTIVATE OUTPUT WHILE GRASPING HARD TISSUE SUCH AS BONE OR HIGHLY CALCIFIED TISSUE, OR HARD OBJECTS SUCH AS METAL CLIPS, STAPLER, OTHER INSTRUMENTS, OR FORCEPS, AND OTHERS. OTHERWISE, IT MAY CAUSE THE PROBE TIP TO BE SCRATCHED OR COME INTO DIRECT CONTACT WITH THE METAL AREA OF THE GRASPING SECTION AS THE HEAT GENERATED BY THE FRICTION BETWEEN THE HARD OBJECT AND THE PROBE TIP COULD CAUSE WEAR/DEFORMING/SPLIT/PROTRUDING/PARTIAL SEPARATING OF THE TISSUE PAD. IN TURN, THE PROBE TIP MAY BREAK BEFORE DISPLAYING AN ERROR WINDOW OR GENERATING AN ALARM TONE. 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 FIELD PERFORMANCE FOR THIS DEVICE.

    Additional Manufacturer Narrative · 0

    THIS DEVICE HAS BEEN RETURNED FOR EVALUATION, BUT HAS NOT YET BEGUN. THE INVESTIGATION IS ONGOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION OR WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 0

    THE CUSTOMER CONFIRMED THE USER UNDERSTOOD THE CHARACTERISTIC IF (ITM) INTELLIGENT TISSUE MONITORING AND POSSIBILITY THAT (ITM) INTELLIGENT TISSUE MONITORING CAN'T DETECT THE TISSUE ALREADY CUT. THE PROCEDURE WAS THERAPEUTIC AND THE PATIENT WAS UNDER GENERAL ANESTHESIA. NO EXTENSION OF THE PROCEDURE WHICH THE USER CONSIDERS TO BE A SERIOUS DETERIORATION IN THE STATE OF HEALTH OF ANY PERSON TO WHICH THIS MEDICAL DEVICE COULD HAVE BEEN A CONTRIBUTORY CAUSE AND NO OTHER DEVICES WERE INVOLVED IN THE EVENT.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED TO OLYMPUS THAT DURING HEPATIC SURGERY USING THIS ULTRASONIC SURGICAL DEVICE, THE PROBE TIP SPLIT/BROKE, FELL INTO THE PATIENT'S BODY AND WAS RETRIEVED USING A FORCEPS. THE PROCEDURE WAS COMPLETED WITH SIMILAR DEVICE. NO DELAY IN PROCEDURE. THE CUSTOMER FURTHER PROVIDED THE SETTINGS FOR THE ULTRASONIC GENERATOR USED WITH THE DEVICE. THE SOFTWARE INSTALLED WAS VERSION 2.00. INTELLIGENT TISSUE MONITORING (ITM) WAS TURNED ON, IS USUALLY KEPT ON, AND WAS NOT CHANGED DURING THE PROCEDURE. THE DEVICE WAS USED FOR TWO HOURS. THERE WERE NO REPORTS OF PATIENT OR USER HARM ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    637233 THUNDERBEAT 5 MM, 20 CM, FRONT-ACTUATED GRIP TYPE S ULTRASONIC SURGICAL DEVICE GEI AOMORI OLYMPUS CO., LTD. TB-0520FCS 26K 01 04953170383571

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention GENERATOR