BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 10378666 · Received August 7, 2020

    Report

    Report Number
    8010047-2020-05375
    Event Type
    Malfunction
    Date Received
    August 7, 2020
    Date of Event
    July 17, 2020
    Report Date
    November 19, 2020
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    GEI
    UDI-DI
    04953170409677
    PMA / PMN Number
    K172610
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE HAS BEEN RETURNED AND AN EVALUATION COMPLETED FOR IT. THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE THIS INFORMATION. PLEASE SEE THE UPDATES IN SECTIONS: D4 (LOT #), D10, G4, G7, H2, H3, H4, H6, AND H10. KR910812 IS THE DEVICE PACKAGE LOT #; ACTUAL LOT # ON THE DEVICE IS KR910679. THE DEVICE WAS EVALUATED FOR THE ISSUE OF THE BROKEN PROBE. THE USER¿S COMPLAINT WAS CONFIRMED. THE DEVICE WAS ATTACHED TO THE USG-400/ESG-400 AND A PROBE CHECK WAS PERFORMED; THE DEVICE DID NOT PASS THE PROBE CHECK. BOTH SWITCHES WERE CHECKED AND BOTH SWITCHES ARE FUNCTIONAL. A VISUAL INSPECTION ON THE RECEIVED CONDITION WAS PERFORMED ON THE DEVICE; THERE IS SOME TISSUE BUILDUP. THE PTFE PAD (TEFLON PAD) WAS INSPECTED AND FOUND NORMAL WEAR WITH NO METAL EXPOSED. THE DISTAL END OF THE DEVICE WAS INSPECTED UNDER A MICROSCOPE AND FOUND THE PROBE TIP IS BROKEN. THE BROKEN PIECE WAS 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.

    Additional Manufacturer Narrative · 0

    THERE IS MORE INFORMATION ON THE DEVICE EVALUATION. THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE THIS INFORMATION. THE DEVICE HISTORY RECORD REVIEW CONFIRMED THAT DEVICE LOT HAD NO ANOMALY IN INSPECTION. THE DEVICE WAS EVALUATED FOR THE ISSUE OF THE BROKEN PROBE. THE USER¿S COMPLAINT WAS CONFIRMED. 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: 1. 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. 2. 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. 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 & CUT¿ OUTPUT WAS ACTIVATED WHILE GRASPING NOTHING (INCLUDING THE CASE THE USER KEPT ACTIVATING AFTER CUTTING 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, 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 & 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: ·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.

    Additional Manufacturer Narrative · 1

    DUE DILIGENCE WAS EXECUTED FOR THIS EVENT. THE DEVICE IS NOT RETURNED, AS SUCH A DEFINITIVE ROOT CAUSE OF THE REPORTED COMPLAINT CANNOT BE DETERMINED AT THIS TIME. SUPPLEMENTAL REPORT(S) WILL BE FILED AS THE INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    AS REPORTED FOR THIS EVENT, DURING A THERAPEUTIC TOTAL LAPAROSCOPIC HYSTERECTOMY (TLH) AT THE TIME OF ACTIVATION OF SEAL AND CUT, THE DEVICE PROBE BROKE. NO DEVICE FRAGMENT FELL INTO THE PATIENT. THERE WAS NO ADVERSE IMPACT TO THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER SIMILAR DEVICE. THE DEVICE WAS INSPECTED PRIOR TO USE. THERE WERE NO ABNORMALITIES OBSERVED. THE CONNECTION POINTS TO THE GENERATOR WERE INSPECTED. THERE WAS NO CABLE DAMAGE OBSERVED. THE PHYSICIAN WAS TRAINED AND EXPERIENCED ON THE USE OF THE DEVICE. THE NECESSARY PROCEDURAL TIPS AND TECHNIQUES WERE SHARED TO THE FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    843446 THUNDERBEAT 5 MM, 35 CM, FRONT-ACTUATED GRIP TYPE S ULTRASONIC SURGICAL DEVICE GEI OLYMPUS MEDICAL SYSTEMS CORP. TB-0535FCS KR910679 04953170409677

    Patients

    Seq Age Sex Outcome Treatment
    1