BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 17164499 · Received June 20, 2023

    Report

    Report Number
    9614641-2023-00873
    Event Type
    Injury
    Date Received
    June 20, 2023
    Date of Event
    May 19, 2023
    Report Date
    August 25, 2023
    Manufacturer
    AOMORI OLYMPUS CO., LTD.
    Product Code
    GEI
    UDI-DI
    04953170409677
    PMA / PMN Number
    K211838
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO CORRECT B1, B2, B5, D4, D9, H1, H3, H4, AND H6. THE INFORMATION IN B5 WAS INADVERTENTLY LEFT OUT FROM THE INITIAL MDR. THE SUSPECT DEVICE WAS RETURNED TO OLYMPUS WITH LOT NUMBER KR253676. THE PROBE WAS BROKEN AT 15,3 MILLIMETERS FROM THE DISTAL END SITE. THE BROKEN TIP WAS RETURNED. THE EXACT CAUSE OF THE EVENT COULD NOT BE EXCLUSIVELY IDENTIFIED. HOWEVER, BASED ON THE PAST INVESTIGATION RESULTS, THE PROBE BROKE POSSIBLY DUE TO CONTACT WITH A SURGICAL INSTRUMENT OR THE NON-INSULATED AREA OF GRASPING SECTION. 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. 3. THE PROBE BROKE WHEN ADDED LOAD. ADDITIONAL FINDINGS INCLUDE PEELED OFF COATING ON THE JAW; PEELED OFF AND SCRATCHED COATING ON THE H-ELECTRODE WITH PRESENCE OF CONTACT MARK; PEELED PEEK COATING AND CONTACT MARK ON THE PROBE TIP; AND MINOR DEFORMATION ON THE TISSUE PAD. THE PAD WEAR WAS LIKELY CAUSED BY ACTIVATION IN SEAL & CUT MODE PERFORMED ON TISSUE TWISTED BY GRASPING SECTION. THE INVESTIGATION IS ONGOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE FINAL LEGAL MANUFACTURER'S FINAL INVESTIGATION. 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 FINAL INVESTIGATION, THERE IS NO CHANGE TO THE LIKELY CAUSE OF THE BROKEN PROBE THAT WAS REPORTED IN THE PREVIOUS SUBMISSION. THE EVENT CAN BE DETECTED/PREVENTED BY FOLLOWING THE INSTRUCTIONS FOR USE (IFU) 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, 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.¿ ¿IF THE GRASPING SECTION, METAL-EXPOSED AREA AROUND IT OR THE PROBE TIP GETS STUCK TO 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.¿ THIS SUPPLEMENTAL REPORT INCLUDES INFORMATION ADDED TO H6. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Additional Manufacturer Narrative · 0

    AT THIS TIME OLYMPUS HAS NOT RECEIVED THIS DEVICE BACK FOR TESTING AND EVALUATION. SHOULD THE DEVICE BE RETURNED, AN EVALUATION WILL BE COMPLETED, AND A FOLLOW UP REPORT WILL BE SUBMITTED. THE INVESTIGATION IS ONGOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 0

    THE THUNDERBEAT 5 MM, 35 CM, FRONT-ACTUATED GRIP TYPE S PROBE BROKE OFF INSIDE THE PATIENT.

    Description of Event or Problem · 0

    THE DISTRIBUTOR REPORTED TO OLYMPUS ON BEHALF OF THE CUSTOMER THE THUNDERBEAT 5 MM, 35 CM, FRONT-ACTUATED GRIP TYPE S PROBE BROKE. THE REPORTED ISSUE OCCURRED APPROXIMATELY 50-60 MINUTES INTO A THERAPEUTIC TOTAL LAPAROSCOPIC HYSTERECTOMY (TLH) PROCEDURE. THE CUSTOMER CONFIRMED THAT THERE MAY HAVE BEEN ONE OR TWO SEAL AND CUT ALARMS DURING THE INCIDENT. THE PROBE WAS RETRIEVED USING A LAP INSTRUMENT. THE PROCEDURE WAS SUBSEQUENTLY COMPLETED WITH A SIMILAR DEVICE WITH NO DELAY. THERE WAS NO PATIENT/USER HARM OR INJURY REPORTED DUE TO THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1013414 THUNDERBEAT 5 MM, 35 CM, FRONT-ACTUATED GRIP TYPE S ULTRASONIC SURGICAL DEVICE GEI AOMORI OLYMPUS CO., LTD. TB-0535FCS KR253676 04953170409677

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention GENERATORS ESG-400 & USG 400