BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 15992030 · Received December 15, 2022

    Report

    Report Number
    9614641-2022-00771
    Event Type
    Malfunction
    Date Received
    December 15, 2022
    Date of Event
    November 11, 2022
    Report Date
    January 19, 2023
    Manufacturer
    AOMORI OLYMPUS CO., LTD.
    Product Code
    GEI
    UDI-DI
    14953170409674
    PMA / PMN Number
    K211838
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    UPON REVIEW IT WAS DETERMINED THE LOT NUMBERS OF THE DEVICES WERE SWITCHED IN THE INITIAL REPORT OF THE CUSTOMER. THE LOT NUMBER RETURNED FOR THIS EVENT "EITHER PROBE OR TEFLON PAD CAME OFF" IS DEVICE ACTUAL LOT NUMBER KR233504 WITH BATCH LOT NUMBER KR239769. THE DEVICE IS RETURNED, AND AN EVALUATION COMPLETED FOR IT. THE DEVICE WAS ATTACHED TO THE USG-400/ESG-400 AND A PROBE CHECK WAS PERFORMED; THE DEVICE FAILED THE PROBE CHECK. BOTH SWITCHES WERE CHECKED AND FOUND TO BE FUNCTIONAL. A VISUAL INSPECTION OF THE AS RECEIVED CONDITION WAS PERFORMED FOR THE DEVICE. THERE IS SOME RUST LOCATED ON THE DISTAL END. THE PTFE PAD (TEFLON PAD) WAS INSPECTED AND FOUND TO BE SEPARATED, THOUGH NOT DETACHED, FROM THE JAW EXPOSING METAL. IN ADDITION, FOREIGN RESIDUE WAS ALSO SEEN ON THE TEFLON PAD AND JAWS. THE DISTAL END OF THE DEVICE WAS INSPECTED UNDER THE MICROSCOPE AND FOUND NO VISUAL DAMAGE TO THE PROBE UNIT. THE WIPER MOVER JAWS ARE MOVING AS INTENDED AND STILL INTACT WITH THE HAND PIECE. THE HANDLE LOAD IS NORMAL. THE ROTATION OF THE KNOB TORQUE IS NORMAL AND SMOOTH. THE USER¿S COMPLAINT WAS CONFIRMED. EVALUATION IS ONGOING. SUPPLEMENTAL REPORT(S) WILL BE SUBMITTED WHEN ANY RELEVANT NEW INFORMATION IS AVAILABLE.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED THE LEGAL MANUFACTURER'S FINAL INVESTIGATION. PLEASE SEE THE UPDATES IN SECTIONS H4, H6, AND H10. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO DEVIATIONS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. BASED ON THE RESULTS OF THE INVESTIGATION, A DEFINITIVE ROOT CAUSE CANNOT BE IDENTIFIED. HOWEVER, THE FOLLOWING STEP-BY-STEP SCENARIO LIKELY CAUSED THE EVENT: 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 FOLLOWING INFORMATION IS INCLUDED IN THE INSTRUCTIONS FOR USE (IFU): ¿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.¿ OLYMPUS WILL CONTINUE TO MONITOR THE PERFORMANCE OF THIS DEVICE.

    Description of Event or Problem · 0

    AS REPORTED FOR THIS EVENT BY THE CUSTOMER, DURING AN UNKNOWN PROCEDURE THE DEVICE TIP, EITHER THE PROBE OR THE TEFLON PAD, CAME OFF. A REPLACEMENT GENERATOR MACHINE WAS BROUGHT TO THE OPERATING ROOM, AS ANOTHER DEVICE HAD BEEN USED PRIOR TO THIS ONE AND FAILED WITH A CIRCUIT ERROR MESSAGE WHICH HAD NOT CLEARED UPON UNHOOKING AND RE-HOOKING THE DEVICE NOR WITH TURNING THE DEVICE OFF AND ON AGAIN. THE FIRST DEVICE WAS HOOKED TO THE SECOND GENERATOR, BUT THE ERROR MESSAGE WAS STILL BEING RECEIVED. AT THIS POINT, THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A THIRD NEW SIMILAR DEVICE. THERE IS NO HARM OR ADVERSE IMPACT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1996063 THUNDERBEAT 5 MM, 35 CM, FRONT-ACTUATED GRIP TYPE S ULTRASONIC SURGICAL DEVICE GEI AOMORI OLYMPUS CO., LTD. TB-0535FCS KR233504 14953170409674

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Male TB-0535FCS LOT # KR233457/KR239778.| TWO GENERATORS.