BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 13603138 · Received February 25, 2022

    Report

    Report Number
    8010047-2022-03595
    Event Type
    Malfunction
    Date Received
    February 25, 2022
    Date of Event
    February 2, 2022
    Report Date
    March 25, 2022
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    GEI
    UDI-DI
    04953170383540
    PMA / PMN Number
    K211838
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    DUE DILIGENCE WAS EXECUTED FOR THIS EVENT. IT IS NOT KNOWN WHO TRAINED THE DOCTOR. IT IS ALSO NOT KNOW IF THE PROCEDURAL TIPS AND TECHNIQUES INSTRUCTIONS THAT WERE DISTRIBUTED ON (B)(6) 2013 HAVE BEEN SHARED WITH THE USER FACILITY. IT IS NOT KNOWN IF THE CONNECTION POINTS TO THE GENERATOR WERE INSPECTED. THE DEVICE IS RETURNED BUT THE DEVICE EVALUATION IS NOT YET COMPLETED. 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

    DEVICE HAS BEEN RETURNED AND EVALUATED. THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE THIS INFORMATION. PLEASE SEE THE UPDATES IN SECTIONS: D4, D9, G3, G6, H2, H3, H4, H6, AND H10. ACTUAL DEVICE ACTUAL LOT NUMBER (LOT #) IS KR151474; LOT# KR150681 IS DEVICE PACKAGE LOT #. DEVICE HISTORY RECORD REVIEW INDICATES THAT THE DEVICE WAS MANUFACTURED AND TESTED IN ACCORDANCE WITH ALL APPLICABLE PROCEDURES AND MET ALL FINAL PRODUCT RELEASE CRITERIA AT INSPECTION. 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 LARGE AMOUNT OF TISSUE BUILD UP LOCATED NEAR THE DISTAL END. THE PTFE TEFLON PAD (TISSUE PAD) WAS INSPECTED AND FOUND IT WORN WITH DRIED FOREIGN RESIDUE AND PARTIALLY SPLIT IN A LATERAL DIRECTION. HOWEVER, THE WEARING DID NOT EXPOSE ANY METAL. 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. THE EXACT CAUSE OF THE EVENT CANNOT BE EXCLUSIVELY IDENTIFIED. HOWEVER BASED ON PAST INVESTIGATIONS, THE BROKEN PROBE POSSIBLY OCCURRED DUE TO CONTACT WITH A SURGICAL INSTRUMENT OR THE NON-INSULATED AREA OF GRASPING SECTION. THE DETAILED STEP-BY-STEP SCENARIO IS BELOW. CONTACT WITH HARD TISSUE, METAL, OR A SURGICAL INSTRUMENT: 1. DURING OUTPUT IN SEAL AND CUT MODE, THE PROBE CAME IN CONTACT WITH HARD TISSUE, METAL OR A SURGICAL INSTRUMENT. CONSEQUENTLY, A SCRATCH WAS MADE ON THE PROBE. 2. THE PROBE RECEIVED AN OUTPUT LOAD IN SEAL AND CUT MODE OR RECEIVED A LOAD WHEN GRASPING TISSUE. AS A RESULT, THE PROBE CRACKED FROM THE SCRATCH. 3. THE PROBE BROKE WITH ADDED LOAD. CONTACT WITH NON-INSULATED AREA OF GRASPING SECTION: 1. THE DISTAL END OF THE TISSUE PAD WAS WORN AWAY BECAUSE SEAL AND CUT OUTPUT WAS ACTIVATED WHILE GRASPING NOTHING (INCLUDING THE CASE THE USER KEPT ACTIVATING AFTER CUTTING TISSUE). 2. THE TISSUE PAD WAS WORN, CAUSING THE NON-INSULATED OF THE GRASPING SECTION TO TOUCH THE PROBE. 3. SEAL AND CUT OUTPUT WAS ACTIVATED UNDER THIS SITUATION, THEN 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 AND CUT MODE OR RECEIVED A LOAD WHEN GRASPING TISSUE. AS A RESULT, THE PROBE CRACKED FROM THE SCRATCH. 5. THE PROBE BROKE WITH ADDED LOAD. THE INSTRUCTIONS FOR USE INCLUDES THE FOLLOWING STATEMENTS THAT WARN AGAINST THE ISSUE: ·DO NOT ACTIVATE OUTPUT IN SEAL AND 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 AND 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, 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.

    Description of Event or Problem · 0

    AS REPORTED FOR THIS EVENT BY THE OLYMPUS REPRESENTATIVE, AT THE END OF A THERAPEUTIC LAPAROSCOPIC HYSTERECTOMY, THE DEVICE PROBE BROKE OFF AND FELL INTO THE PATIENT. THE BROKEN PIECE WAS RETRIEVED FROM PATIENT WITH A GRASPER. THERE IS NO HARM OR ADVERSE IMPACT TO THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A SHORT DELAY THAT WAS NOT CLINICALLY RELEVANT. THE PATIENT DID NOT NEED ADDITIONAL ANESTHESIA. THE DOCTOR WAS PERFORMING SEAL AND CUT WITH SETTINGS AT THE TIME WERE SEAL AND CUT 2, SEAL 1 AT THE TIME OF THE EVENT. THE DEVICE WAS INSPECTED BEFORE USE WITH NO ANOMALIES NOTED. THERE WAS NO CABLE DAMAGE. THE TRANSDUCER CORDS OR THE CORDS OF ANY OTHER MEDICAL DEVICE (E.G. ELECTROCARDIOGRAPH) WERE NOT BUNDLED. THE DOCTOR IS EXPERIENCED IN THE USE OF THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1196253 THUNDERBEAT 5 MM, 35 CM, FRONT-ACTUATED GRIP TYPE S ULTRASONIC SURGICAL DEVICE GEI OLYMPUS MEDICAL SYSTEMS CORP. TB-0535FCS KR151474 04953170383540

    Patients

    Seq Age Sex Outcome Treatment
    1 Female