BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 12542140 · Received September 28, 2021

    Report

    Report Number
    8010047-2021-12396
    Event Type
    Malfunction
    Date Received
    September 28, 2021
    Date of Event
    August 18, 2021
    Report Date
    November 23, 2021
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    GEI
    UDI-DI
    04953170383557
    PMA / PMN Number
    K211838
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE RETURNED DEVICE EVALUATION IS NOW COMPLETED. THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE THIS INFORMATION. THE DATA FOR PERSONAL INFORMATION (INITIAL REPORTER AND PATIENT) CANNOT BE MADE AVAILABLE DUE TO RESTRICTIONS IMPOSED BY THE EU GENERAL DATA PROTECTION REGULATION (GDPR, ART. 44-49). ACTUAL DEVICE LOT NUMBER IS 0XK 28; OXK IS PACKAGE LOT NUMBER. THE DEVICE HISTORY RECORD REVIEW CONFIRMED THAT THE DEVICE LOT HAD NO ANOMALY IN INSPECTION AND HIGH FREQUENCY OUTPUT. THE RETURNED DEVICE WAS EVALUATED. IT WAS OBSERVED THAT THE PROBE OF THE DEVICE WAS BROKEN OFF. THE BROKEN PIECE WAS NOT RETURNED. THE TEFLON PAD OF THE DEVICE WAS ALSO PARTIALLY PEELED AND SEPARATED FROM THE DEVICE. 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. IT IS LIKELY THE PEELING OF THE TISSUE PAD OCCURRED THUS: 1) THE TISSUE PAD WAS WORN AWAY BECAUSE NO TISSUE WAS BEING GRASPED BETWEEN THE GRASPING SECTION AND THE PROBE TIP WHEN THE DEVICE WAS ACTIVATED OUTPUT IN SEAL & CUT MODE FOR/AFTER A TRANSECTION OF TISSUE. 2) THE TISSUE PAD WAS EXCESSIVELY HEATED DUE TO FRICTION BETWEEN THE GRASPING SECTION AND THE PROBE TIP. THIS CAUSED THE TISSUE PAD TO BE PARTIALLY PEELED AWAY. 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 · 0

    INFORMATION OF INITIAL REPORTER, IS NOT YET AVAILABLE. 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 THE INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 0

    AS REPORTED FOR THIS EVENT, DURING A LIVER RESECTION OPEN PROCEDURE, WHEN THE DEVICE HAD BEEN IN USE FOR A LONG TIME, A BREAK WAS OBSERVED FOR THE DEVICE ON THE LIVER TISSUE. HOWEVER, THE DEVICE PROBE TIP BROKE OFF OUTSIDE THE PATIENT. THERE WAS NO HARM OR ADVERSE IMPACT TO THE PATIENT. THE PROCEDURE WAS CONTINUED AND SUCCESSFULLY COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1440476 THUNDERBEAT 5 MM, 35 CM, FRONT-ACTUATED GRIP TYPE S ULTRASONIC SURGICAL DEVICE GEI OLYMPUS MEDICAL SYSTEMS CORP. TB-0535FCS 0XK 28 04953170383557

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown