BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 15469673 · Received September 23, 2022

    Report

    Report Number
    9614641-2022-00347
    Event Type
    Malfunction
    Date Received
    September 23, 2022
    Date of Event
    July 27, 2022
    Report Date
    November 22, 2022
    Manufacturer
    AOMORI OLYMPUS CO., LTD.
    Product Code
    GEI
    UDI-DI
    04953170409677
    PMA / PMN Number
    K211838
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CUSTOMER REPORTED TWO EVENTS OF DEVICES FAILED WITH BROKEN PROBES OCCURRING WITHIN THREE WEEKS OF EACH OTHER. THESE EVENTS ARE CAPTURED IN MEDWATCHES WITH PATIENT IDENTIFIERS (B)(6). 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 DEVICE EVALUATION AND THE LEGAL MANUFACTURER'S FINAL INVESTIGATION. THE DEVICE WAS RETURNED AND AN EVALUATION WAS COMPLETED FOR IT. DURING INSPECTION, OLYMPUS CONFIRMED THE REPORTED EVENT, THE PROBE WAS BROKEN. ADDITIONALLY, THE COATING OF THE GRASPING SECTION WAS PARTIALLY PEELED OFF, PEELING OF THE COATING OF THE PROBE, AND AN ERROR CODE WAS NOTED, HOWEVER, THESE DEFECTS ARE NOT CONSIDERED SEVERE ENOUGH TO CAUSE A POTENTIAL ADVERSE EVENT. 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) DURING THE OUTPUT ACTIVATION IN SEAL & CUT MODE, THE PROBE WAS CONTACTING HARD TISSUE, METAL OBJECTS OR SURGICAL INSTRUMENTS. 2) DUE TO ULTRASONIC VIBRATION, THE COATING OF THE PROBE PEELED OFF. ALSO, SCRATCHES WERE GENERATED. 3) A FORCE TO ACTIVATE THE OUTPUT IN SEAL & CUT MODE, OR A FORCE TO GRASP THE TISSUE WAS APPLIED TO THE PROBE. THEREFORE, CRACKS WERE GENERATED AT THE SCRATCHED AREA AND THE ERROR OCCURRED. 4) A FORCE WAS APPLIED TO THE PROBE CAUSING IT TO BREAK. THE FOLLOWING INFORMATION IS INCLUDED IN THE INSTRUCTIONS FOR USE (IFU): ¿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 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

    AS REPORTED FOR THIS EVENT BY THE CUSTOMER, DURING A THERAPEUTIC COELIO SIGMOIDECTOMY PROCEDURE AN ERROR MESSAGE WAS RECEIVED FOR THE DEVICE AFTER ONE CLIP OF THE DEVICE. SUBSEQUENTLY, THE DEVICE WORKED AGAIN, AND AFTER TWO MINUTES THE DEVICE PROBE BROKE OFF, FALLING INTO THE PATIENT BODY. ONCE LOCATED IN THE PATIENT STOMACH, THE BROKEN PIECE WAS RETRIEVED. THE PROCEDURE WAS COMPLETED WITH A NEW SIMILAR DEVICE WITH A DELAY OF 15 MINUTES. THE DELAY HAD NO CLINICAL IMPACT. THERE IS NO HARM OR ADVERSE IMPACT TO THE PATIENT. THE INTELLIGENT TISSUE MONITORING (ITM) SETTING IS USUALLY ON DURING A PROCEDURE; WHETHER THE ITM WAS ON FOR THIS PROCEDURE IS NOT CERTAIN, BUT THE SETTING WAS NOT CHANGED IN THE DURATION OF THE PROCEDURE. THE USER UNDERSTOOD THE FUNCTIONALITY OF ITM, THAT ITM IS ONLY A SUPPORT FUNCTION AND MAY NOT ALWAYS DETECT IF THE TISSUE IS CUT. PER THE USER, THE EVENT WAS POTENTIALLY DANGEROUS TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2793019 THUNDERBEAT 5 MM, 35 CM, FRONT-ACTUATED GRIP TYPE S ULTRASONIC SURGICAL DEVICE GEI AOMORI OLYMPUS CO., LTD. TB-0535FCS KR233570 04953170409677

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown