BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 15775562 · Received November 10, 2022

    Report

    Report Number
    9614641-2022-00596
    Event Type
    Malfunction
    Date Received
    November 10, 2022
    Date of Event
    October 17, 2022
    Report Date
    May 3, 2023
    Manufacturer
    AOMORI OLYMPUS CO., LTD.
    Product Code
    GEI
    UDI-DI
    04953170409677
    PMA / PMN Number
    K211838
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE HAS BEEN RETURNED BUT THE DEVICE EVALUATION IS NOT YET BEGUN. AS SUCH, A DEFINITIVE ROOT CAUSE OF THE REPORTED COMPLAINT CANNOT BE DETERMINED AT THIS TIME.SUPPLEMENTAL REPORT(S) WILL BE FILED AS ANY RELEVANT NEW INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION HAS BEEN RECEIVED FOR THIS EVENT. THE DEVICE RETURNED DEVICE HAS BEEN EVALUATED. THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE THIS INFORMATION. CUSTOMER WILL NOT PROVIDE ANY PATIENT INFORMATION. THE DEVICE ACTUAL LOT NUMBER (#) IS KR233364; LOT # KR239748 IS DEVICE PACKAGE LOT #. THE DEVICE WAS ATTACHED TO THE USG-400/ESG-400 AND A PROBE CHECK WAS PERFORMED; THE DEVICE FAILED THE PROBE CHECK WITH ERROR CODE U509. BOTH SWITCHES WERE CHECKED AND FOUND BOTH SWITCHES ARE FUNCTIONAL. A VISUAL INSPECTION ON THE RECEIVED CONDITION WAS PERFORMED ON THE DEVICE; THERE IS SOME TISSUE BUILD UP. THE PTFE PAD (TEFLON PAD) WAS INSPECTED AND FOUND IT HAS NORMAL WEAR WITH NO METAL EXPOSED AND NO ABNORMALITY. THE DISTAL END OF THE DEVICE WAS INSPECTED UNDER A MICROSCOPE AND FOUND THE PROBE DETACHED; MISSING PORTION IS NOT RETURNED. THE WIPER MOVEMENT IS NORMAL. THE CONSISTENCY OF MOVEMENT OF THE HANDLE AND JAW IS NORMAL. THE HANDLE LOAD IS NORMAL. THE ROTATION OF THE KNOB TORQUE IS NORMAL AND SMOOTH. EVALUATION IS ONGOING. SUPPLEMENTAL REPORT(S) WILL BE SUBMITTED WHEN ANY RELEVANT NEW INFORMATION IS AVAILABLE.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE LEGAL MANUFACTURER'S FINAL INVESTIGATION. CORRECTION TO D9 ¿ 15-NOV-2022. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO DEVIATIONS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. ALTHOUGH A DEFINITIVE ROOT CAUSE CANNOT BE IDENTIFIED, THE FOLLOWING STEP-BY-STEP SCENARIO LIKELY CAUSED THE EVENT: 1. THE OUTPUT WAS ACTIVATED IN SEAL & CUT MODE WHILE THE GRASPING SECTION WAS GRASPING THICK TISSUE. THEREFORE, THE PROBE AND THE TISSUE PAD CAME INTO CONTACT AT THE REAR END OF THE GRASPING SECTION, CAUSING THE TISSUE PAD TO WEAR OUT. 2. THE NON-INSULATED AREA OF THE GRASPING SECTION AND THE PROBE CAME INTO CONTACT DUE TO WEAR OF THE TISSUE PAD. 3. THE OUTPUT IN SEAL & CUT WAS ACTIVATED WHILE THE NON-INSULATED AREA OF THE GRASPING SECTION WAS IN CONTACT WITH THE PROBE. AS A RESULT, A CONTACT MARK DEVELOPED. 4. A FORCE TO ACTIVATE THE OUTPUT IN SEAL &CUT MODE OR A FORCE TO GRASP TISSUE WAS APPLIED TO THE PROBE. THEREFORE, CRACKS DEVELOPED AT A CONTACT MARK CAUSING THE PROBE DAMAGE ERROR. 5. A FORCE WAS APPLIED TO THE PROBE CAUSING IT TO BREAK. THE FOLLOWING INFORMATION IS INCLUDED IN THE INSTRUCTIONS FOR USE (IFU): ¿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.¿ ¿DURING THE TREATMENT, DO NOT ACTIVATE OUTPUT WHILE APPLYING THE PROBE TIP TO THE TISSUE WITH A STRONG FORCE, GRASPING THICK TISSUE, OR TWISTING THE HANDLE. ALSO, DO NOT INSERT THE HANDLE WHILE THE HANDLE IS TWISTED WITH RESPECT TO THE TISSUE, DO NOT GRASP IT, AND DO NOT ACTIVATE THE OUTPUT. OTHERWISE, THE PROBE TIP AND/OR GRASPING SECTION MAY BE DAMAGED, WHICH MAY RESULT IN FALLING OF THE PROBE TIP AND/OR TISSUE PAD.¿ OLYMPUS WILL CONTINUE TO MONITOR THE PERFORMANCE OF THIS DEVICE.

    Description of Event or Problem · 0

    AS REPORTED FOR THIS EVENT BY THE CUSTOMER, DURING A THERAPEUTIC TOTAL LAPAROSCOPIC HYSTERECTOMY (TLH) PROCEDURE, THE DEVICE PROBE BROKE OFF DURING COLPOTOMY. THE PROCEDURE WAS COMPLETED WITH A NEW SIMILAR DEVICE. NO OTHER DEVICE WAS REPLACED DURING THE PROCEDURE. THERE IS NO HARM OR ADVERSE IMPACT TO THE PATIENT.

    Description of Event or Problem · 0

    ADDENDUM NOV 16, 2022: THE EVENT OCCURRED AT THE END OF THE PROCEDURE DURING COLPOTOMY. A PROBE DAMAGE ERROR CODE WAS RECEIVED AT THE TIME OF THE EVENT. THE DEVICE WAS PARTIALLY DETACHED IN THE PATIENT BUT DID NOT FALL OFF. THE DEVICE PROBE TIP BROKE OFF OUTSIDE THE PATIENT. THE DOCTOR WAS PERFORMING SEAL AND CUT WITH SETTINGS 1:1 AT THE TIME OF THE EVENT. THERE WAS ONLY TWO MINUTES DELAY TO THE COMPLETION OF THE PROCEDURE AS WAS REQUIRED TO OPEN A NEW DEVICE. THE PATIENT DID NOT NEED ADDITIONAL ANESTHESIA. THE DEVICE WAS INSPECTED PRIOR TO USE WITH NO ANOMALY NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1911389 THUNDERBEAT 5 MM, 35 CM, FRONT-ACTUATED GRIP TYPE S ULTRASONIC SURGICAL DEVICE GEI AOMORI OLYMPUS CO., LTD. TB-0535FCS KR233364 04953170409677

    Patients

    Seq Age Sex Outcome Treatment
    1 Female