BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 16142384 · Received January 11, 2023

    Report

    Report Number
    9614641-2023-00042
    Event Type
    Malfunction
    Date Received
    January 11, 2023
    Date of Event
    December 15, 2022
    Report Date
    March 1, 2023
    Manufacturer
    AOMORI OLYMPUS CO., LTD.
    Product Code
    GEI
    UDI-DI
    04953170383540
    PMA / PMN Number
    K211838
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE 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. DEVICE ACTUAL LOT NUMBER IS KR266900; LOT NUMBER KR240142 IS FOR THE DEVICE PACKAGE. 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 THE TIME OF 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 MINOR TISSUE BUILD UP NOTED. THE PTFE PAD TEFLON PAD (TISSUE PAD) WAS INSPECTED AND FOUND IT HAS NORMAL WEAR ON THE PROXIMAL SIDE WITH NO METAL EXPOSED. HOWEVER, MINOR SIGNS OF DRIED FOREIGN RESIDUE WERE NOTICED ON THE WALLS. THE DISTAL END OF THE DEVICE WAS INSPECTED UNDER A MICROSCOPE AND FOUND THE PROBE IS DETACHED WITH MISSING PORTION RETURNED. THE PROBE HAD CRACKED FROM THE SCRATCH THEN BROKEN OFF. THE FRACTURE SURFACE OF THE PROBE WAS CHECKED AND FOUND THAT CRACKS HAD DEVELOPED FROM THE NON-INSULATED SIDE OF GRASPING SECTION. THERE WAS A CONTACT MARK ON THE NON-INSULATED OF THE GRASPING SECTION INDICATING THAT THE NON-INSULATED AREA WAS IN CONTACT WITH THE PROBE. 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. FURTHER TESTING WAS UNABLE TO PERFORMED AS THE PROBE IS DAMAGED AND DETACHED. THE EXACT CAUSE OF THE EVENT COULD NOT BE EXCLUSIVELY IDENTIFIED. HOWEVER BASED ON THE DEVICE EVALUATION AND THE PAST INVESTIGATION RESULTS, THE PROBE DAMAGE ERROR AND THE PROBE BROKEN AND THE ERROR POSSIBLY OCCURRED BY THE FOLLOWING MECHANISM: 1. SEAL AND CUT OUTPUT WAS ACTIVATED WHILE GRASPING A THICK TISSUE WITH THE TIP OF THE GRASPING SECTION. THE PROXIMAL SIDE OF THE TISSUE PAD COME IN CONTACT TO THE PROBE. AS A RESULT, THE PAD WAS WORN. 2. THIS CAUSED THE NON-INSULATED OF THE GRASPING SECTION TO TOUCH THE PROBE. 3. SEAL AND CUT OUTPUT WAS ACTIVATED UNDER THIS SITUATION, 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 AND THE PROBE DAMAGE ERROR OCCURRED. 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. ¿ DURING THE TREATMENT, DO NOT ACTIVATE OUTPUT WHILE APPLYING THE PROBE TIP TO THE TISSUE WITH A STRONG FORCE, GRASPING THICK TISSUE, OR TWISTING THE HANDLE. ALSO, DO NOT INSERT THE HANDLE WHILE THE HANDLE IS TWISTED WITH RESPECT TO THE TISSUE, DO NOT GRASP IT, AND DO NOT ACTIVATE THE OUTPUT. OTHERWISE, THE PROBE TIP AND/OR GRASPING SECTION MAY BE DAMAGED, WHICH MAY RESULT IN FALLING OF THE PROBE TIP AND/OR TISSUE PAD.

    Additional Manufacturer Narrative · 0

    FULL NAME OF THE FACILITY IS (B)(6) HOSPITAL AUTHORITY AN AFFILIATE OF (B)(6). CUSTOMER REPORTED SIX DEVICES FROM THE SAME LOT THAT FAILED WITH A BROKEN PROBE. THESE EVENTS ARE CAPTURED IN MEDWATCHES WITH PATIENT IDENTIFIERS (B)(6). THREE OF THE DEVICES ARE BEING RETURNED AND ARE REPRESENTED BY THE MEDWATCHES WITH PATIENT IDENTIFIERS (B)(6). THE OTHER THREE DEVICES ARE DISCARDED AND ARE REPRESENTED BY THE MEDWATCHES WITH PATIENT IDENTIFIERS (B)(6). THIS MEDWATCH IS FOR THE PATIENT IDENTIFIER (B)(6). THE DEVICE IS NOT RETURNED, AS SUCH A DEFINITIVE ROOT CAUSE OF THE REPORTED COMPLAINT CANNOT BE DETERMINED AT THIS TIME. THIS EVENT IS UNDER INVESTIGATION. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION OR UPON RECEIVING ADDITIONAL INFORMATION.

    Description of Event or Problem · 0

    AS REPORTED FOR THIS EVENT BY THE CUSTOMER TO THE OLYMPUS REPRESENTATIVE, A TOTAL OF SIX DEVICES FROM THE SAME PACKAGE LOT FAILED DURING TWO PROCEDURES. THE PROCEDURES WERE THERAPEUTIC LAPAROSCOPIC SUPRACERVICAL HYSTERECTOMY (LSH) AND LAPAROSCOPIC MYOMECTOMY. THREE DEVICES FAILED DURING EACH PROCEDURE. PROBE DAMAGE ERROR MESSAGES WERE RECEIVED FOR EACH OF THE FAILED DEVICE. THE PROCEDURES WERE OF APPROXIMATELY ONE HOUR DURATION AND WERE COMPLETED WITHOUT ANY DELAY AND WITHOUT ANY ADVERSE IMPACT TO THE COMPLETION OF THE PROCEDURE USING A SIMILAR DEVICE. THERE IS NO HARM OR ADVERSE IMPACT TO EITHER PATIENT. ONE OF THE DEVICES HAD THE PROBE TIP BREAK OFF AND FALL INTO THE PATIENT. THE BROKEN PIECE WAS RETRIEVED FROM THE PATIENT WITH A GRASPER. TWO OF THE OTHER FIVE DEVICES HAD THE PROBE BREAK OFF UPON BEING REMOVED FROM THE SURGICAL FIELD AND WHILE BEING EXAMINED. THE REMAINING THREE DEVICES HAD THE PROBES BREAK OFF WHILE BEING CLEANED. THREE OUT OF THE SIX DEVICES ARE BEING RETURNED. AT THIS TIME, THE ASSOCIATION OF THE DEVICE TO THE PROCEDURE OR THE PARTICULAR FAILURE CANNOT BE SPECIFIED OTHER THAN ALL THE SIX DEVICES HAD THE PROBE BROKEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1178681 THUNDERBEAT 5 MM, 35 CM, FRONT-ACTUATED GRIP TYPE S ULTRASONIC SURGICAL DEVICE GEI AOMORI OLYMPUS CO., LTD. TB-0535FCS KR266900 04953170383540

    Patients

    Seq Age Sex Outcome Treatment
    1 Female