BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 17746313 · Received September 14, 2023

    Report

    Report Number
    9614641-2023-01318
    Event Type
    Injury
    Date Received
    September 14, 2023
    Date of Event
    August 16, 2023
    Report Date
    October 5, 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
    KS
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE SUSPECT DEVICE WAS RETURNED TO OLYMPUS KOREA LOGISTICS CENTER FOR DISPOSAL. ADDITIONAL INFORMATION IS BEING REQUESTED. THE INVESTIGATION IS ONGOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION. H3 OTHER TEXT: THE DEVICE WAS RETURNED TO OLYMPUS KOREA LOGISTICS FOR DISPOSAL.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE LEGAL MANUFACTURER'S FINAL INVESTIGATION AND DEVICE EVALUATION. THE DEVICE WAS EVALUATED BY OLYMPUS (VIA PHOTO), AND THE CUSTOMER¿S REPORTED COMPLAINT (BROKEN PROBE) WAS CONFIRMED. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO DEVIATIONS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. IT HAS BEEN LESS THAN 1 YEAR SINCE THE SUBJECT DEVICE WAS MANUFACTURED. BASED ON THE RESULTS OF THE INVESTIGATION, THE ROOT CAUSE OF THE BROKEN BROKE COULD NOT BE DETERMINED. HOWEVER, THE BROKEN PROBE WAS LIKELY DUE TO CONTACTING OTHER SURGICAL INSTRUMENTS, OR NON-INSULATED AREAS AS DESCRIBED IN THE MECHANISMS BELOW. MECHANISM #1 1. DURING OUTPUT ACTIVATION IN SEAL & CUT MODE, THE PROBE ENCOUNTERED HARD TISSUE, METAL, OR SURGICAL INSTRUMENTS. THIS CAUSED SCRATCHES ON THE PROBE. THIS ALSO CAUSED A SHORT CIRCUIT ERROR. 2. A FORCE TO ACTIVATE THE OUTPUT IN SEAL & CUT MODE, OR A FORCE TO GRASP THE BODY TISSUE WAS APPLIED TO THE PROBE. THEREFORE, CRACKS WERE BRANCHING FROM THE SCRATCHES ON THE PROBE, AND THE PROBE DAMAGE ERROR WAS DETECTED. 3. A FORCE WAS APPLIED TO THE PROBE CAUSING IT TO BREAK. MECHANISM #2 1. GRASPING SECTION WAS CLOSED WITHOUT GRASPING ANYTHING WHILE THE DEVICE WAS ACTIVATING IN SEAL & CUT MODE (THIS INCLUDES AFTER TISSUE RESECTION) CAUSING THE TISSUE PAD TO WEAR OUT. 2. SINCE THE TISSUE PAD WAS WORN OUT, THE NON-INSULATED AREA OF THE GRASPING SECTION AND THE DISTAL END OF THE PROBE CAME INTO CONTACT. 3. THE OUTPUT WAS ACTIVATED IN SEAL & CUT MODE IN THE STATE OF DESCRIPTION STATED ABOVE. THIS CAUSED SCRATCHES (CONTACT MARKS) ON THE DISTAL END OF THE PROBE AND THE GRASPING SECTION. THE SCRATCHES INDICATE THAT THE DISTAL END OF THE PROBE WAS CONTACTING THE DISTAL END OF THE GRASPING SECTION. THIS ALSO CAUSED A SHORT CIRCUIT ERROR. 4. A FORCE TO ACTIVATE THE OUTPUT IN SEAL & CUT MODE, OR A FORCE TO GRASP THE BODY TISSUE WAS APPLIED TO THE PROBE. THEREFORE, CRACKS WERE BRANCHING FROM THE SCRATCHES (CONTACT MARKS) ON THE PROBE. 5. A FORCE WAS APPLIED TO THE PROBE CAUSING IT TO BREAK. THE EVENT CAN BE DETECTED/PREVENTED BY FOLLOWING THE INSTRUCTIONS FOR USE (IFU) 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, 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.¿ THIS SUPPLEMENTAL REPORT INCLUDES ADDITIONAL INFORMATION REGARDING THE EVENT. INFORMATION HAS BEEN ADDED TO B5. ALSO, AN UPDATE HAS BEEN MADE TO H3. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Description of Event or Problem · 0

    AN OLYMPUS REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT A SHORT CIRCUIT ERROR AND PROBE DAMAGER ERROR WERE OBSERVED WHILE USING THE THUNDERBEAT 5 MM, 35 CM, FRONT-ACTUATED GRIP TYPE S. AFTER WHICH, THE PROBE TIP WAS BROKEN AND WAS REMOVED IMMEDIATELY. THE ISSUE OCCURRED DURING A THERAPEUTIC MYOMECTOMY PROCEDURE AND WAS COMPLETED WITH A SIMILAR DEVICE WITHOUT DELAY. THE DEVICE WAS ON SEAL & CUT 1 MODE. THE DEVICE WAS INSPECTED BEFORE USE WITHOUT ANY ISSUES NOTED. THERE WAS NO FURTHER PATIENT IMPACT REPORTED DUE TO THE EVENT.

    Description of Event or Problem · 0

    THE FOLLOWING ADDITIONAL INFORMATION WAS RECEIVED: THE PROBE TIP FELL INTO THE PATIENT'S BODY, BUT WAS REMOVED BY THE MEDICAL STAFF AT THAT TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2252572 THUNDERBEAT 5 MM, 35 CM, FRONT-ACTUATED GRIP TYPE S ULTRASONIC SURGICAL DEVICE GEI AOMORI OLYMPUS CO., LTD. TB-0535FCS 34K20 04953170383540

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention