BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 15951533 · Received December 9, 2022

    Report

    Report Number
    9614641-2022-00743
    Event Type
    Injury
    Date Received
    December 9, 2022
    Date of Event
    November 10, 2022
    Report Date
    January 16, 2023
    Manufacturer
    AOMORI OLYMPUS CO., LTD.
    Product Code
    GEI
    UDI-DI
    14953170409674
    PMA / PMN Number
    K211838
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE REFERENCED IN THIS REPORT WAS NOT RETURNED TO OLYMPUS FOR EVALUATION. THE DEFINITIVE CAUSE OF THE USER'S EXPERIENCE CANNOT BE DETERMINED AT THIS TIME. THE INVESTIGATION IS ONGOING. THIS REPORT WILL BE UPDATED UPON COMPLETION OF THE INVESTIGATION OR UPON RECEIPT OF ADDITIONAL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE LEGAL MANUFACTURER'S FINAL INVESTIGATION. THE DEVICE WAS DISCARDED BY THE CUSTOMER. THE DEVICE HISTORY RECORD WAS UNABLE TO BE REVIEWED FOR THIS DEVICE SINCE THE LOT NUMBER WAS NOT PROVIDED. HOWEVER, OLYMPUS ONLY RELEASES PRODUCTS TO MARKET THAT MEET ALL MANUFACTURING SPECIFICATIONS AND FINAL PRODUCT RELEASE CRITERIA. THE EXACT CAUSE OF THE EVENT COULDN¿T BE EXCLUSIVELY IDENTIFIED. HOWEVER BASED ON THE PAST INVESTIGATION RESULTS, THE ERROR AND THE PROBE BROKEN POSSIBLY OCCURRED DUE TO CONTACT WITH A SURGICAL INSTRUMENT OR THE NON-INSULATED AREA OF GRASPING SECTION. THE DETAILED MECHANISMS ARE SHOWN BELOW: 1. DURING OUTPUT IN SEAL & CUT MODE, THE PROBE CAME IN CONTACT WITH HARD TISSUE, METAL OR A SURGICAL INSTRUMENT. CONSEQUENTLY, A SCRATCH WAS MADE ON THE PROBE. 2. THE PROBE RECEIVED AN OUTPUT LOAD IN SEAL & CUT MODE OR RECEIVED A LOAD WHEN GRASPING TISSUE. AS A RESULT, THE PROBE CRACKED FROM THE SCRATCH AND THE ERROR OCCURRED. 3. THE PROBE BROKE WHEN ADDED LOAD. 1. THE DISTAL END OF THE TISSUE PAD WAS WORN AWAY BECAUSE ¿SEAL & CUT¿ OUTPUT WAS ACTIVATED WHILE GRASPING NOTHING (INCLUDING THE CASE THE USER KEPT ACTIVATING AFTER CUTTING TISSUE). 2. THE TISSUE PAD WAS WORN AWAY, CAUSING THE NON-INSULATED OF THE GRASPING SECTION TO TOUCH THE PROBE. 3. ¿SEAL & CUT¿ OUTPUT WAS ACTIVATED UNDER THIS SITUATION, THEN THE SCRATCHES INDICATING THAT THE PROBE AND GRASPING SECTION WERE IN CONTACT WITH EACH OTHER WERE MADE. 4. THE PROBE RECEIVED AN OUTPUT LOAD IN SEAL & CUT MODE OR RECEIVED A LOAD WHEN GRASPING TISSUE. AS A RESULT, THE PROBE CRACKED FROM THE SCRATCH AND THE ERROR OCCURRED. 5. THE PROBE BROKE WHEN ADDED LOAD. IT IS LIKELY THE PEELING OF THE TISSUE PAD OCCURRED BY THE FOLLOWING MECHANISM: 1) THE TISSUE PAD WAS WORN AWAY BECAUSE NO TISSUE WAS BEING GRASPED BETWEEN THE GRASPING SECTION AND THE PROBE TIP WHEN THE DEVICE WAS ACTIVATED OUTPUT IN SEAL & CUT MODE FOR/AFTER A TRANSECTION OF TISSUE. 2) THE TISSUE PAD WAS EXCESSIVELY HEATED DUE TO FRICTION BETWEEN THE GRASPING SECTION AND THE PROBE TIP. THIS CAUSED THE TISSUE PAD TO BE PARTIALLY PEELED AWAY. THE EVENT CAN BE DETECTED/PREVENTED BY FOLLOWING THE INSTRUCTIONS FOR USE WHICH STATE: "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. 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. 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, OR OTHER INSTRUMENTS (E.G., UTERINE MANIPULATOR, 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/SPLITTING/PROTRUDING/PARTIAL SEPARATING OF THE TISSUE PAD. IN TURN, THE PROBE 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." OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTS DURING A LAPAROSCOPIC HEMI NEPHRECTOMY USING A THUNDERBEAT, THE PROBE DETACHED AND FELL INTO THE PATIENT AND WAS SUBSEQUENTLY REMOVED USING A GRASPER. ANOTHER THUNDERBEAT WAS OPENED (1¿2-MINUTE DELAY TO OPEN A SECOND THUNDERBEAT). AFTER SWITCHING DEVICES, THE CUSTOMER EXPERIENCED AN UNSPECIFIED ERROR MESSAGE. UPON INSPECTION OF THE GENERATOR, THE FIELD SAFETY ENGINEER (FSE) NOTICED THAT THE 'ITM' WAS SWITCHED TO 'OFF'. THE FSE SWITCHED THIS BACK ON AGAIN. THE PHYSICIAN (USER) WAS UNAWARE IT HAD BEEN TURNED OFF. THE SETTINGS WERE ALSO SET TO 3-1 (INSTEAD OF 1-1). THE PHYSICIAN WAS A FIRST-TIME USER OF THE DEVICE. THE PHYSICIAN HAD RECENTLY SWITCHED FROM USING A COMPETITOR DEVICE. THE PHYSICIAN STATED THUNDERBEAT TB "GOT HER OUT OF TROUBLE" BY CONTROLLING THE BLEEDING. A PHYSICIAN COLLEAGUE EXPLAINED TO THE USER PHYSICIAN THAT THE ITM SIGNALS WHEN TISSUE IS TRANSECTED AND THEREFORE, WITH ITM TURNED OFF, SHE WAS OVER ACTIVATING AGAINST THE TISSUE PAD. IT APPEARS THIS CAUSED THE PAD TO DETACH, AND SUBSEQUENT PROBE DAMAGE OCCURRED. THE FSE EXPLAINED THE ISSUE OF OVER-ACTIVATING AND THE ITM PROPERTIES AND THE CASE CONTINUED WITHOUT ISSUE (USING THE SECOND PROBE). FURTHER TRAINING OF NEW USERS IS BOOKED AT NEXT AUDIT. NO COMPLAINT FROM THE SURGEON AS SHE WAS VERY HAPPY WITH THE PERFORMANCE OF THUNDERBEAT BUT ACKNOWLEDGED MORE PRACTICE WAS NEEDED. THERE WAS NO INJURY TO THE PATIENT AS A RESULT OF THIS OCCURRENCE. THE THUNDERBEAT THAT BROKE WAS DISCARDED BY THE FACILITY AND CANNOT BE RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2842307 THUNDERBEAT 5 MM, 35 CM, FRONT-ACTUATED GRIP TYPE S ULTRASONIC SURGICAL DEVICE GEI AOMORI OLYMPUS CO., LTD. TB-0535FCS UNKNOWN 14953170409674

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention