BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 17860555 · Received October 3, 2023

    Report

    Report Number
    9614641-2023-01450
    Event Type
    Injury
    Date Received
    October 3, 2023
    Date of Event
    September 12, 2023
    Report Date
    November 9, 2023
    Manufacturer
    AOMORI OLYMPUS CO., LTD.
    Product Code
    GEI
    UDI-DI
    04953170383540
    PMA / PMN Number
    K211838
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST
    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. ADDITIONALLY, TO PROVIDE CORRECTION TO THE INITIAL WITH INFORMATION INADVERTENTLY LEFT OUT AND TO PROVIDE A CORRECTION TO THE INITIAL (H3). THE CUSTOMER DOES NOT KNOW THE VERSION OF THE SOFTWARE, IF THE (ITM) INTELLIGENT TISSUE MONITORING WAS ON WHEN THE THUNDERBEAT WAS USED, OR IF THE SETTING OF ITM IS USUALLY ON WHEN USED. THE DEVICE WAS RETURNED TO OLYMPUS FOR INSPECTION, AND THE CUSTOMER'S COMPLAINT/REPORTABLE MALFUNCTION WAS CONFIRMED. 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 AND THE PAST INVESTIGATION RESULTS, THE ERROR AND THE PROBE BROKEN POSSIBLY OCCURRED BY THE FOLLOWING MECHANISM: 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 AND THE ERROR OCCURRED. 4) DUE TO CONTINUOUS USE OF THE DEVICE, THE CRACKS ON THE PROBE PROGRESSED. THIS LED TO BREAKAGE OF THE PROBE. HOWEVER, A SPECIFIC ROOT CAUSE OF THE RECOVERY OF THE BROKEN PROBE WHICH LED TO AN EXTENDED PROCEDURE TIME COULD NOT BE DETERMINED. THE EVENT CAN BE PREVENTED BY FOLLOWING THE INSTRUCTIONS FOR USE WHICH STATE: "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." IN ADDITION, THE FOLLOWING NON-REPORTABLE MALFUNCTIONS WERE FOUND DURING THE DEVICE EVALUATION: PEELING OFF OF THE COATING OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Additional Manufacturer Narrative · 0

    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 REPORTED TO OLYMPUS THAT DURING HIATAL HERNIA OPERATION, AFTER FIVE OR SIX USES OF THIS THUNDERBEAT, THE ALARM SOUNDED. THE DEVICE HAD COME OUT AND ONE OF THE SCISSOR JAWS HAD BECOME DETACHED, AS REPORTED. THE JAW WAS FOUND WITH DIFFICULTY, AND WAS REMOVED. THE PROCEDURE WAS PROLONGED FOR FIFTEEN MINUTES AND A DELAY IN COAGULATION WAS NOTED. THE PROCEDURE WAS COMPLETED WITH A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT OR USER INJURY ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    414716 THUNDERBEAT 5 MM, 35 CM, FRONT-ACTUATED GRIP TYPE S ULTRASONIC SURGICAL DEVICE GEI AOMORI OLYMPUS CO., LTD. TB-0535FCS KR271548 04953170383540

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention