BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 10537959 · Received September 15, 2020

    Report

    Report Number
    8010047-2020-06536
    Event Type
    Malfunction
    Date Received
    September 15, 2020
    Date of Event
    August 21, 2020
    Report Date
    November 13, 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

    ADDITIONAL INFORMATION HAS BEEN RECEIVED FOR THIS EVENT. THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE THIS INFORMATION. THE ISSUE OCCURRED AT THE END OF THE PROCEDURE. THE PROCEDURE WAS COMPLETED WITH A SECOND DEVICE (PRODUCT INFORMATION NOT PROVIDED). CONCOMITANT DEVICES INFORMATION WAS NOT PROVIDED. THE PROBE THAT BROKE DID NOT FALL AS IT WAS STILL PARTIALLY ATTACHED. THERE WAS NO VISUAL DAMAGE TO THE TEFLON PAD. THERE WERE NO METAL EXPOSED ON THE DEVICE JAW. AT THE TIME OF THE EVENT, THE GENERATOR SETTINGS WERE 1:1. THE GENERATOR DISPLAYED A PROBE DAMAGE ERROR. THE DEVICE WAS INSPECTED PRIOR TO USE AND NO ABNORMALITIES WERE FOUND. THE CONNECTION POINTS OF THE GENERATOR WERE INSPECTED AND FOUND TO BE SECURED. NO CABLE DAMAGE WAS OBSERVED AND NO CORDS/CABLES WERE BUNDLED DURING USE.

    Additional Manufacturer Narrative · 0

    THE 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. THE ACTUAL LOT # ON THE DEVICE IS KR911733 AND IS KR912161 IS THE PACKAGE LOT # THE CUSTOMER RETURNED THE DEVICE, LOT NUMBER KR911733, FOR THE EVALUATION OF THE REPORTED ISSUE OF A BROKEN PROBE DURING ACTIVATION OF SEAL AND CUT. 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 LARGE AMOUNT OF TISSUE BUILD UP. THE PTFE PAD (TEFLON PAD) WAS INSPECTED AND FOUND IT HAS NORMAL WEAR, NO METAL EXPOSED, NO ABNORMALITY BUT MINOR SIGNS OF CHAR MARKS. THE DISTAL END OF THE DEVICE WAS INSPECTED UNDER A MICROSCOPE AND FOUND THE PROBE IS DETACHED, MISSING PORTION RETURNED. THE WIPER MOVEMENT NO MOVEMENT DUE TO TISSUE BUILD UP. THE CONSISTENCY OF MOVEMENT OF THE HANDLE AND JAW IS TIGHT. THE HANDLE LOAD IS HEAVY. THE ROTATION OF THE KNOB TORQUE IS NORMAL AND SMOOTH. THE DEVICE HISTORY RECORD FOR THE LOT INDICATED NO ANOMALY WITH THE EVENT-RELATED ITEMS. THE ROOT CAUSE OF THE EVENT CANNOT BE EXCLUSIVELY IDENTIFIED. HOWEVER BASED ON PAST INVESTIGATION RESULTS, THE PROBE BREAK LIKELY OCCURRED DUE TO CONTACT WITH A SURGICAL INSTRUMENT OR THE NON-INSULATED AREA OF GRASPING SECTION. THE DETAILED STEP-BY-STEP SCENARIOS ARE OUTLINED 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 WHEN 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 WHEN 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

    THERE IS NO ADDITIONAL INFORMATION AVAILABLE FOR THIS EVENT AS YET. DEVICE IS RETURNED BUT THE DEVICE EVALUATION IS NOT COMPLETED. 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. DEVICE EVALUATION IS NOT YET COMPLETED.

    Description of Event or Problem · 1

    AS REPORTED FOR THIS EVENT, DURING A THERAPEUTIC PROCEDURE AT THE TIME OF SEAL AND CUT, THE DEVICE PROBE BROKE. THE PROCEDURE WAS COMPLETED WITH ANOTHER SIMILAR DEVICE. THERE IS NO REPORTED PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1002990 THUNDERBEAT 5 MM, 35 CM, FRONT-ACTUATED GRIP TYPE S ULTRASONIC SURGICAL DEVICE GEI OLYMPUS MEDICAL SYSTEMS CORP. TB-0535FCS KR911733 04953170409677

    Patients

    Seq Age Sex Outcome Treatment
    1