BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THUNDERBEAT 5 MM, 20 CM, FRONT-ACTUATED GRIP TYPE S

    MDR report key: 17689847 · Received September 6, 2023

    Report

    Report Number
    9614641-2023-01289
    Event Type
    Injury
    Date Received
    September 6, 2023
    Date of Event
    August 3, 2023
    Report Date
    October 13, 2023
    Manufacturer
    AOMORI OLYMPUS CO., LTD.
    Product Code
    GEI
    UDI-DI
    04953170383571
    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 FROM THE CUSTOMER AND ADDITIONAL INFORMATION BASED ON THE LEGAL MANUFACTURER'S FINAL INVESTIGATION. UPDATED FIELDS: B1, B2, B5, H1, H6. CORRECTED: H3. THE ACTUAL PRODUCT WAS RETURNED TO SOUTH KOREA LOGISTICS CENTER FOR THE DISPOSAL. THE LEGAL MANUFACTURER'S INVESTIGATION CONFIRMED THE ALLEGATION. FROM THE PHOTOS IN COMPLAINT INFORMATION BY SOUTH KOREA, IT WAS CONFIRMED THAT THE PROBES BROKEN OFF. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO DEVIATIONS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. THE OCCURRENCE OF THE REPORTED PROBLEM CAN BE PREVENTED BY ADHERING TO THE INSTRUCTIONS FOR USE (IFU) WHICH STATES THE FOLLOWING: ¿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. THE EXACT CAUSE COULD NOT BE DETERMINED. HOWEVER, BASED ON INVESTIGATION RESULTS IN THE PAST, THE PROBE MIGHT HAVE CONTACTED WITH OTHER SURGICAL INSTRUMENTS, OR NON-INSULATED AREA AS DESCRIBED BELOW. THIS MIGHT HAVE CAUSED THE PROBE TO BREAK. <CONTACT WITH A SURGICAL INSTRUMENT> 1.HARD TISSUE, A METAL OBJECT OR A SURGICAL INSTRUMENT HAD BEEN IN CONTACT WITH THE PROBE DURING THE OUTPUT ACTIVATION IN SEAL & CUT MODE CAUSING THE SCRATCHES ON THE PROBE. 2.THE DEVICE WAS ACTIVATED IN SEAL &CUT MODE OR WHILE THE GRASPING SECTION WAS GRASPING TISSUE. THIS APPLIED A FORCE TO THE SCRATCHED AREA OF THE GRASPING SECTION, CAUSING THIS AREA TO HAVE CRACKS. 3.A FORCE WAS APPLIED TO THE PROBE CAUSING IT TO BREAK. <CONTACT WITH NON-INSULATED AREA OF GRASPING SECTION> 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, 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. THEREFORE, SCRATCHES (CONTACT MARKS) WERE MADE ON THE DISTAL END OF THE PROBE AND THE GRASPING SECTION, INDICATING THAT THEY CAME INTO CONTACT WITH EACH OTHER. 4.THE DEVICE WAS ACTIVATED IN SEAL &CUT MODE OR WHILE THE GRASPING SECTION WAS GRASPING TISSUE. THIS APPLIED A FORCE TO THE SCRATCHED AREA OF THE GRASPING SECTION, CAUSING THIS AREA TO HAVE CRACKS. 5.A FORCE WAS APPLIED TO THE PROBE CAUSING IT TO BREAK. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE. H3 OTHER TEXT : DEVICE WAS DISCARDED AT KOREAN LOGISTIC SITE

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED TO OLYMPUS FOR EVALUATION AND THE CUSTOMER'S ALLEGATION WAS CONFIRMED, THE DEVICE EVALUATION FOUND THAT THE PROBE TIP WAS BROKEN. THE INVESTIGATION IS ONGOING AND FOLLOW UP WITH THE USER FACILITY IS CURRENTLY BEING PERFORMED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION OR IF ANY ADDITIONAL INFORMATION IS PROVIDED BY THE USER FACILITY.

    Description of Event or Problem · 0

    OLYMPUS FURTHER RECEIVED INFORMATION THAT THE PROBE TIP FELL INTO THE PATIENT'S BODY AND REMOVED BY MEDICAL STAFF AT THAT TIME.

    Description of Event or Problem · 0

    THE OLYMPUS REPRESENTATIVE (ON BEHALF OF THE CUSTOMER) REPORTED TO OLYMPUS, THE THUNDERBEAT 5MM, 20 CM, FRONT-ACTUATED GRIP TYPE S PROBE TIP WAS BROKEN DURING THE PROCEDURE, THE PROBE TIP WAS IMMEDIATELY REMOVED BY THE MEDICAL STAFF. THE DEVICE WAS INSPECTED PRIOR TO USE, THE ISSUE WAS FOUND DURING A THERAPEUTIC PYLORUS PRESERVING PANCREATICODUODENECTOMY (PPPD) PROCEDURE WHICH WAS COMPLETED WITH A SIMILAR DEVICE, AND WITHOUT DELAY. THERE WERE NO REPORTS OF PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1056867 THUNDERBEAT 5 MM, 20 CM, FRONT-ACTUATED GRIP TYPE S ULTRASONIC SURGICAL DEVICE GEI AOMORI OLYMPUS CO., LTD. TB-0520FCS 31K30 04953170383571

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention