BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 16803081 · Received April 24, 2023

    Report

    Report Number
    9614641-2023-00559
    Event Type
    Injury
    Date Received
    April 24, 2023
    Date of Event
    March 21, 2023
    Report Date
    September 1, 2023
    Manufacturer
    AOMORI OLYMPUS CO., LTD.
    Product Code
    GEI
    UDI-DI
    04953170383540
    PMA / PMN Number
    K211838
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE LEGAL MANUFACTURER'S FINAL INVESTIGATION AND DEVICE EVALUATION. ADDITIONALLY, TO PROVIDE CORRECTIONS TO THE INITIAL WITH INFORMATION INADVERTENTLY LEFT OUT AND TO UPDATE THE INITIAL (D9 AND H3). THE CUSTOMER CONFIRMED THE VERSION OF THE SOFTWARE WAS VER. 2.00. THE SETTING OF ITM WAS "ON" AND USUALLY "ON". THE USER UNDERSTOOD THE ITM (INTELLIGENT TISSUE MONITORING) CLEARLY. THE USER DID NOT CHANGE THE SETTING OF ITM DURING THE PROCEDURE. THE PROCEDURE WAS A LAPAROSCOPIC LIVER SEGMENTECTOMY. THE FIRST SOUND SIGNAL FROM THE GENERATOR AFTER 10 MINUTES AND OBSERVATION OF A PART SLIPPING AT THE MIDDLE OF THE LOWER JAW OF THE PLIERS. THE DEVICE WAS RETURNED TO OLYMPUS FOR INSPECTION, AND THE CUSTOMER'S COMPLAINT/REPORTABLE MALFUNCTION WAS CONFIRMED. THE COMPLETE EVALUATION RESULTS ARE AS FOLLOWED: THE TISSUE PAD IN THE GRASPING SECTION IS MISSING. THE METAL PART OF THE GRASPING SECTION IS VISIBLE THROUGH THE TISSUE PAD. THE TISSUE PAD IN THE GRASPING SECTION WAS TORN WITH MISSING PART. THERE WAS A MARK IN THE PROBE WHICH CAME IN CONTACT WITH THE NON-INSULATED AREA OF GRASPING SECTION AND WAS ABRADED AGAINST IT. THERE WAS A MARK IN THE NON-INSULATED AREA OF GRASPING SECTION WHICH CAME IN CONTACT WITH THE PROBE AND WAS ABRADED AGAINST IT. 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, IT IS LIKELY THE ERROR AND FELL OFF OF THE TISSUE PAD OCCURRED BY THE FOLLOWING MECHANISM: 1. GRASPING SECTION WAS CLOSED WITHOUT GRASPING ANYTHING WHILE THE OUTPUT IN SEAL & CUT MODE WAS ACTIVATED, (THIS INCLUDES AFTER TISSUE RESECTION) CAUSING THE TISSUE PAD TO WEAR INTENSIVELY AND FALL OFF. 2. THE NON-INSULATED AREA OF THE GRASPING SECTION AND THE PROBE CAME INTO CONTACT DUE TO WEAR OF THE TISSUE PAD. 3. THE OUTPUT IN SEAL & CUT WAS ACTIVATED WHILE THE NON-INSULATED AREA OF THE GRASPING SECTION WAS IN CONTACT WITH THE PROBE. AS A RESULT, A CONTACT MARK WAS DEVELOPED AND IT WAS CAUSING AN ERROR. HOWEVER, THE ROOT CAUSE COULD NOT BE DETERMINED. THE EVENT CAN BE PREVENTED BY FOLLOWING THE INSTRUCTIONS FOR USE WHICH STATE: ¿ 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. IN ADDITION, THE FOLLOWING NON-REPORTABLE MALFUNCTIONS WERE FOUND DURING THE DEVICE EVALUATION: PEELING OFF OF THE COATING. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Additional Manufacturer Narrative · 0

    TO DATE, THIS DEVICE HAS NOT BEEN RETURNED FOR EVALUATION. THE INVESTIGATION IS ONGOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION OR WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED TO OLYMPUS THAT DURING LAPAROSCOPIC RESECTION OF IVB SEGMENT USING THIS ULTRASONIC SURGICAL DEVICE, AN ERROR MESSAGE APPEARED ON THE OLYMPUS GENERATOR (ENERGY TRANSMISSION DEFECT). AFTER TEN (10) MINUTES, A PIECE OF THE BLADE DETACHED FROM THE SCISSOR WAS OBSERVED AND WAS FOUND INTRA-ABDOMINALLY, LENGTHENING THE OPERATING TIME. THE USER CHANGED ELECTROSURGERY TECHNIQUE TO CONTINUE THE OPERATION. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION WERE UNSUCCESSFUL. THERE WERE NO REPORTS OF FURTHER PATIENT OR USER HARM ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    466469 THUNDERBEAT 5 MM, 35 CM, FRONT-ACTUATED GRIP TYPE S ULTRASONIC SURGICAL DEVICE GEI AOMORI OLYMPUS CO., LTD. TB-0535FCS KR214822 04953170383540

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Unknown Other| R