BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 20094580 · Received August 29, 2024

    Report

    Report Number
    9614641-2024-01730
    Event Type
    Injury
    Date Received
    August 29, 2024
    Date of Event
    July 15, 2024
    Report Date
    October 2, 2024
    Manufacturer
    AOMORI OLYMPUS CO., LTD.
    Product Code
    GEI
    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

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE DEVICE EVALUATION AND THE LEGAL MANUFACTURER'S FINAL INVESTIGATION. THE DEVICE WAS RETURNED TO OLYMPUS AND EVALUATED BY THE LEGAL MANUFACTURER (VIA PHOTO). THE PROBE WAS CONFIRMED TO BE BROKEN. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO DEVIATIONS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. IT HAS BEEN OVER 1 YEAR SINCE THE SUBJECT DEVICE WAS MANUFACTURED. BASED ON THE RESULTS OF THE INVESTIGATION, THE PROBE LIKELY ENCOUNTERED OTHER SURGICAL INSTRUMENTS, OR THE NON-INSULATED AREA 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. 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. 3. A FORCE WAS APPLIED TO THE PROBE CAUSING IT TO BREAK. MECHANISM #2: 1. THE 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, 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 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. 4. CRACKS STARTING FROM SCRATCHES (CONTACT MARKS) DUE TO THE SEAL & CUT OUTPUT OR THE LOAD OF TISSUE GRASPING BEING APPLIED TO THE PROBE. 5. A FORCE WAS APPLIED TO THE PROBE CAUSING IT TO BREAK. HOWEVER, THE ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED. 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 AN UPDATE TO H3 FROM THE INITIAL MEDWATCH. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Additional Manufacturer Narrative · 0

    THE EVALUATION OF THE DEVICE IS ONGOING. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PROBE TIP OF THE SUBJECT DEVICE WAS BROKEN DURING A THERAPEUTIC SUBTOTOTAL GASTRECTOMY. THE PROBE TIP FELL INTO THE PATIENT'S ABDOMINAL CAVITY AND WAS RETRIEVED WITH FORCEPS WITHIN 10 SECONDS. THE PROCEDURE WAS COMPLETED USING A SIMILAR DEVICE WITHOUT REPORTS OF PATIENT HARM. THE DEVICE WAS INSPECTED PRIOR TO USE WITHOUT ANY ISSUES NOTED. THE REMOVED PROBE TIP WAS DISPOSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1990369 THUNDERBEAT 5 MM, 35 CM, FRONT-ACTUATED GRIP TYPE S ULTRASONIC SURGICAL DEVICE GEI AOMORI OLYMPUS CO., LTD. TB-0535FCS 2ZK06

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention