BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 15778653 · Received November 11, 2022

    Report

    Report Number
    9614641-2022-00601
    Event Type
    Malfunction
    Date Received
    November 11, 2022
    Date of Event
    October 28, 2022
    Report Date
    January 25, 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
    KS, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE HAS BEEN RETURNED AND EVALUATED. THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE THIS INFORMATION. THE DEVICE ACTUAL LOT NUMBER (#) IS KR233449; LOT # KR239766 IS PACKAGE LOT #. THE RETURNED 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 APPROXIMATELY 16 MM OF THE PROBE IS DETACHED. THE MISSING PORTION OF THE PROBE WAS NOT RETURNED FOR EVALUATION. 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

    CUSTOMER REPORTED THREE EVENTS OF THE DEVICE FAILED WITH A BROKEN PROBE IN THE MONTH OF (B)(6) 2022. THESE EVENTS ARE CAPTURED IN MEDWATCHES WITH PATIENT IDENTIFIERS (B)(6) (B)(6) 2022, (B)(6) (B)(6) 2022), AND (B)(6) (B)(6) 2022). THIS MEDWATCH IS FOR THE PATIENT IDENTIFIER (B)(6). THE DEVICE IS NOT RETURNED, AS SUCH A DEFINITIVE ROOT CAUSE OF THE REPORTED COMPLAINT CANNOT BE DETERMINED AT THIS TIME. THIS EVENT IS UNDER INVESTIGATION. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION OR UPON RECEIVING ADDITIONAL INFORMATION.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE LEGAL MANUFACTURER'S FINAL INVESTIGATION AND CORRECTION TO G2. PLEASE SEE UPDATES TO G2, H6, AND H10. 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. SEAL & CUT¿ OUTPUT WAS ACTIVATED WHILE GRASPING A THICK TISSUE WITH THE TIP OF THE GRASPING SECTION. THE PROXIMAL SIDE OF THE TISSUE PAD COME IN CONTACT TO THE PROBE. AS A RESULT, THE PAD WAS WORN AWAY. 2. THE TISSUE PAD WAS WORN AWAY, CAUSING THE NON-INSULATED OF THE GRASPING SECTION TO TOUCH THE PROBE. 3. ¿SEAL & CUT¿ OUTPUT WAS ACTIVATED UNDER THIS SITUATION, THE SCRATCHES INDICATING THAT THE PROBE AND GRASPING SECTION WERE IN CONTACT WITH EACH OTHER WERE MADE. 4. 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 AND THE ERROR OCCURRED. 5. THE PROBE BROKE WHEN ADDED SOME LOAD. 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 LAPAROSCOPIC TOTAL HYSTERECTOMY PROCEDURE, THE DEVICE PROBE BROKE OFF AND FELL INTO THE PATIENT. THE BROKEN PIECE WAS RETRIEVED FROM THE PATIENT WITH A GRASPER. A NEW SIMILAR DEVICE WAS NOT USED TO COMPLETE THE PROCEDURE AS THE PROCEDURE WAS ALMOST COMPLETED. THE DOCTOR USED CAUTERY FROM VAGINAL OPENING TO COMPLETE THE PROCEDURE INSTEAD. THERE WAS NO DELAY TO THE COMPLETION OF THE PROCEDURE. THE PATIENT DID NOT NEED ADDITIONAL ANESTHESIA. THERE IS NO HARM OR ADVERSE IMPACT TO THE PATIENT. AN UNKNOWN ERROR MESSAGE WAS RECEIVED AT THE TIME OF THE EVENT. THE DOCTOR WAS PERFORMING CUT AND COAGULATION FUNCTION AT THE TIME OF THE EVENT. THE DEVICE WAS INSPECTED PRIOR TO USE WITH NO ANOMALY NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2878977 THUNDERBEAT 5 MM, 35 CM, FRONT-ACTUATED GRIP TYPE S ELECTROSURGICAL HANDPIECE, SINGLE-USE GEI AOMORI OLYMPUS CO., LTD. TB-0535FCS KR233449 04953170409677

    Patients

    Seq Age Sex Outcome Treatment
    1 Female