BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THUNDERBEAT 5 MM, 35 CM, FRONT-ACTUATED GRIP

    MDR report key: 11880157 · Received May 25, 2021

    Report

    Report Number
    8010047-2021-06729
    Event Type
    Malfunction
    Date Received
    May 25, 2021
    Date of Event
    March 17, 2021
    Report Date
    May 25, 2021
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    GEI
    UDI-DI
    04953170337574
    PMA / PMN Number
    K111202
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MDR IS BEING SUBMITTED RETROSPECTIVELY AS PART OF A REMEDIATION EFFORT RELATED TO RECENT SYSTEM AND PROCESS CHANGES. AN INVESTIGATION HAS BEEN OPENED TO MANAGE THE ACTIONS RELATED TO REMEDIATION OF THIS ISSUE AND ANY REQUIRED MDR REPORTING. THE PHYSICIAN IS VERY EXPERIENCED AND WAS TRAINED BY AN OLYMPUS REPRESENTATIVE. THE PROCEDURAL TIPS AND TECHNIQUES INSTRUCTIONS THAT WERE DISTRIBUTED ON 09/27/2013 HAVE BEEN SHARED WITH THE USER FACILITY AND ARE POSTED IN EVERY OR ROOM. PATIENT INITIALS ARE (B)(6). CONCOMITANT DEVICES USED IN THIS EVENT ARE OTV-S190 7242872, CLV-S190 7101146, ESG 400 14044W 130001, USG 400 9303303, OTV S7 PROH ¿ HD ¿ 12E, TD-TB400, WA03210A, AND A WOLF 8912.401 10MM 0O OFFSET LAPAROSCOPE. THE DEVICE HISTORY RECORD REVIEW CONFIRMED THAT THE DEVICE LOT HAD NO ANOMALY IN INSPECTION. THE DEVICE WAS RETURNED AND EVALUATED FOR THE ISSUE OF THE BROKEN LOWER JAW. THE DEVICE WAS ATTACHED TO THE USG-400/ESG-400 AND A PROBE CHECK WAS PERFORMED; THE DEVICE FAILED THE PROBE CHECK; 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 HEAVY TISSUE BUILD UP LOCATED NEAR THE DISTAL END. THE PTFE PAD (TEFLON PAD) WAS INSPECTED AND FOUND IT IS WORN ON THE SIDES WITH NO METAL EXPOSED. THE TEFLON PAD ALSO HAS SIGNS OF DRIED FOREIGN RESIDUE. THE DISTAL END OF THE DEVICE WAS INSPECTED UNDER A MICROSCOPE AND FOUND THE PROBE IS DETACHED, MISSING PORTION WAS NOT RETURNED FOR EVALUATION. HEAVY DRIED FOREIGN RESIDUE NEAR THE BREAKAGE POINT OF THE PROBE WAS CAPTURED. 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 PEELING OF THE TISSUE PAD AND ERROR OCCURRED IS LIKELY OCCURRED BY THE FOLLOWING SCENARIO: 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 A SURGICAL INSTRUMENT: DURING OUTPUT IN SEAL & CUT MODE, THE PROBE CAME IN CONTACT WITH HARD TISSUE, METAL OR A SURGICAL INSTRUMENT. CONSEQUENTLY, A SCRATCH WAS MADE ON THE PROBE. 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. THE PROBE BROKE WITH ADDED LOAD. CONTACT WITH NON-INSULATED AREA OF GRASPING SECTION: THE DISTAL END OF THE TISSUE PAD WAS WORN AWAY BECAUSE SEAL & CUT OUTPUT WAS ACTIVATED WHILE GRASPING NOTHING (INCLUDING THE CASE THE USER KEPT ACTIVATING AFTER CUTTING TISSUE). THE TISSUE PAD WAS WORN AWAY, CAUSING THE NON-INSULATED OF THE GRASPING SECTION TO TOUCH THE PROBE. SEAL & 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. 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. THE PROBE BROKE WITH ADDED LOAD. THE INSTRUCTIONS FOR USE INCLUDES THE FOLLOWING STATEMENTS: 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. 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 · 1

    AS REPORTED FOR THIS EVENT, DURING THE END OF A THERAPEUTIC TOTAL LAPAROSCOPIC HYSTERECTOMY, WHILE THE DOCTOR WAS PERFORMING COAGULATION, THE BOTTOM JAW BROKE OFF INTO THE PATIENT. THE BROKEN PIECE WAS RETRIEVED FROM THE PATIENT WITH LAPAROSCOPIC GRASPERS. THERE WAS NO DELAY IN THE PROCEDURE COMPLETION. THERE WAS NO HARM OR ADVERSE IMPACT TO THE PATIENT. THE PATIENT HAD GENERAL ANESTHESIA AND WAS ASLEEP WHEN THE INCIDENT HAPPENED. THE SETTINGS ARE NOT AVAILABLE. THE DEVICE WAS INSPECTED BEFORE USE WITH NO ABNORMALITIES NOTED. THE CONNECTION POINTS TO THE GENERATOR WERE INSPECTED. THERE WAS NO CABLE DAMAGE. THE TRANSDUCER CORDS OR THE CORDS OF ANY OTHER MEDICAL DEVICE (E.G. ELECTROCARDIOGRAPH) WERE NOT BUNDLED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    770592 THUNDERBEAT 5 MM, 35 CM, FRONT-ACTUATED GRIP ULTRASONIC SURGICAL DEVICE GEI OLYMPUS MEDICAL SYSTEMS CORP. TB-0535FC KR103598 04953170337574

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR