BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 15679230 · Received October 27, 2022

    Report

    Report Number
    9614641-2022-00543
    Event Type
    Malfunction
    Date Received
    October 27, 2022
    Date of Event
    October 4, 2022
    Report Date
    December 5, 2022
    Manufacturer
    AOMORI OLYMPUS CO., LTD.
    Product Code
    GEI
    UDI-DI
    04953170383540
    PMA / PMN Number
    K211838
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    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. DUE DILIGENCE WAS EXECUTED FOR THIS EVENT WITH NO RESPONSE FROM CUSTOMER. THE DEVICE ACTUAL LOT NUMBER IS KR233451; LOT NUMBER KR239751 IS DEVICE PACKAGE LOT NUMBER. 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 INSPECTION. THE DEVICE WAS ATTACHED TO THE USG-400/ESG-400 AND A PROBE CHECK WAS PERFORMED; THE DEVICE FAILED THE PROBE CHECK. THE DISTAL END OF THE DEVICE WAS INSPECTED UNDER A MICROSCOPE AND FOUND THE PROBE DETACHED, MISSING PORTION NOT RETURNED. 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 INSPECTION REVEALED THE BREAK STARTED FROM THE ORIGIN OF A CRACK CAUSED TO THE PROBE. THERE WAS A MARK IN THE PROBE WHICH CAME IN CONTACT TO THE NON-INSULATED AREA OF GRASPING SECTION AND WAS ABRADED AGAINST IT. BOTH SWITCHES WERE CHECKED AND FOUND BOTH SWITCHES ARE FUNCTIONAL. A VISUAL INSPECTION ON THE RECEIVED CONDITION WAS PERFORMED ON THE DEVICE; THERE IS SOME TISSUE BUILD UP. THE PTFE TEFLON PAD (TISSUE PAD) WAS INSPECTED AND FOUND IT HAS NORMAL WEAR WITH NO METAL EXPOSED AND NO ABNORMALITY. THE PROXIMAL SIDE OF THE TISSUE PAD WAS WORN. THERE WAS A MARK IN THE NON-INSULATED AREA OF GRASPING SECTION WHICH CAME IN CONTACT WITH THE PROBE AND WAS ABRADED AGAINST IT. THE EXACT CAUSE OF THE EVENT COULDN¿T BE EXCLUSIVELY IDENTIFIED. HOWEVER BASED ON THE INVESTIGATION PHOTOS ATTACHED BY SAN JOSE AND THE PAST INVESTIGATION RESULTS, THE PROBE BROKEN 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 AWAY. 2. THE TISSUE PAD WAS WORN AWAY, CAUSING 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. 5. THE PROBE BROKE WITH SOME 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

    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, DURING AN UNKNOWN PROCEDURE THE DEVICE PROBE TIP BROKE OFF AND FELL INTO THE PATIENT. THE BROKEN PIECE WAS RETRIEVED FROM THE PATIENT. A SECOND DEVICE WAS USED TO CONTINUE THE PROCEDURE. THE SECOND DEVICE FAILED WITH A REGRASPING ERROR. THE PROCEDURE WAS COMPLETED WITH A THIRD DEVICE BELONGING TO ANOTHER MANUFACTURER. THERE IS NO HARM OR ADVERSE IMPACT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2223152 THUNDERBEAT 5 MM, 35 CM, FRONT-ACTUATED GRIP TYPE S ULTRASONIC SURGICAL DEVICE GEI AOMORI OLYMPUS CO., LTD. TB-0535FCS KR233451 04953170383540

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown