BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 15361266 · Received September 6, 2022

    Report

    Report Number
    9614641-2022-00271
    Event Type
    Malfunction
    Date Received
    September 6, 2022
    Date of Event
    August 5, 2022
    Report Date
    October 27, 2022
    Manufacturer
    AOMORI OLYMPUS CO., LTD.
    Product Code
    GEI
    UDI-DI
    04953170383557
    PMA / PMN Number
    K211838
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE IS RETURNED AND AN EVALUATION COMPLETED FOR IT. UPON INSPECTION OF THE DEVICE, IT WAS OBSERVED THAT THE DEVICE PROBE WAS BROKEN. THE BROKEN PIECE WAS NOT RETURNED. THE PROBE TIP HAS CONTACT MARK AT THE FRACTURE SITE. TISSUE PAD HAS MINOR DEFORMATION AND PARTIAL SPLIT. THE JAW HAS SCRATCHED COATING WHICH IS PEELED IN ONE SPOT AND A CONTACT MARK. 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. PLEASE SEE THE UPDATES IN SECTIONS H4, 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. THE WORN AND PARTIALLY TORN OF THE TISSUE PAD COULD HAVE HAPPENED BECAUSE ¿SEAL & CUT¿ OUTPUT WAS ACTIVATED WHILE GRASPING NOTHING WITH THE GRASPING SECTION AND THE PROBE TIP, OR KEPT ACTIVATING THE OUTPUT AFTER A TRANSECTION OF TISSUE. 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, AND THE SHORT CIRCUIT ERROR OCCURRED. 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. 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.¿ ¿IF THE GRASPING SECTION, METAL-EXPOSED AREA AROUND IT OR THE PROBE TIP GETS STICKED 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.¿ OLYMPUS WILL CONTINUE TO MONITOR THE PERFORMANCE OF THIS DEVICE.

    Description of Event or Problem · 0

    CUSTOMER RETURNED THE DEVICE FOR EVALUATION OF 'SHORT-CIRCUIT AND DAMAGE OF THE PROBE ERROR MESSAGES RECEIVED DURING A THERAPEUTIC LAPAROSCOPIC HYSTERECTOMY PROCEDURE AT THE FIRST USE OF THE DEVICE. THE PROCEDURE WAS COMPLETED WITH A NEW SIMILAR DEVICE WITHOUT ANY DELAY. THERE WAS NO HARM OR ADVERSE IMPACT ON THE PATIENT. UPON EVALUATION OF THE RETURNED DEVICE, IT WAS OBSERVED THAT THE DEVICE PROBE WAS BROKEN. THE BROKEN PIECE WAS NOT RETURNED. THIS MEDWATCH IS BEING SUBMITTED FOR THE REPORTABLE ISSUE OF THE BROKEN PROBE AS OBSERVED DURING DEVICE EVALUATION. INTELLIGENT TISSUE MONITORING (ITM) WAS ON FOR THE PROCEDURE, AS IS THE USUAL PRACTICE. HOWEVER, THE ITM SETTING WAS CHANGED DURING THE PROCEDURE. THE USER UNDERSTANDS THE ITM FUNCTIONALITY CLEARLY, WHICH IS THAT THE ITM FUNCTIONALITY IS A SUPPORT FUNCTION AND THERE IS A POSSIBILITY THAT ITM MAY NOT DETECT TISSUE THAT IS ALREADY CUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2561645 THUNDERBEAT 5 MM, 35 CM, FRONT-ACTUATED GRIP TYPE S ULTRASONIC SURGICAL DEVICE GEI AOMORI OLYMPUS CO., LTD. TB-0535FCS KR227540 04953170383557

    Patients

    Seq Age Sex Outcome Treatment
    1 Female USG-400, VERSION 2.00