BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THUNDERBEAT OPEN EXTENDED JAW

    MDR report key: 16465953 · Received March 2, 2023

    Report

    Report Number
    9614641-2023-00289
    Event Type
    Malfunction
    Date Received
    March 2, 2023
    Date of Event
    December 28, 2022
    Report Date
    June 8, 2023
    Manufacturer
    AOMORI OLYMPUS CO., LTD.
    Product Code
    GEI
    UDI-DI
    04953170343315
    PMA / PMN Number
    K211838
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CUSTOMER REPORTED FOUR THUNDERBEAT DEVICES THAT FAILED WITH DETACHED TISSUE PADS ON THE SAME DAY. THESE EVENTS ARE CAPTURED IN MEDWATCHES WITH PATIENT IDENTIFIERS (B)(6). THIS MEDWATCH IS FOR THE PATIENT IDENTIFIER (B)(6). DUE DILIGENCE HAS BEEN PERFORMED FOR THIS EVENT. HOWEVER, CUSTOMER DOES NOT HAVE ANY DETAILS OF THE EVENT AVAILABLE AT THIS TIME. 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.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION HAS BEEN RECEIVED FOR THIS EVENT FROM THE CUSTOMER. CORRECTION IS BEING MADE FOR EVENT DATE. THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE THIS INFORMATION. PLEASE SEE THE UPDATES IN SECTIONS: B3, B5, D10, G3, G6, H2, AND H10.

    Additional Manufacturer Narrative · 0

    DEVICE HAS BEEN RETURNED. THERE IS A CORRECTION OF THE DEVICE MODEL NUMBER AND ASSOCIATED INFORMATION FOR THE DEVICE. THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE THIS INFORMATION.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE DEVICE EVALUATION AND THE LEGAL MANUFACTURER'S FINAL INVESTIGATION. THE DEVICE WAS RETURNED AND AN EVALUATION WAS COMPLETED FOR IT. DURING INSPECTION, OLYMPUS WAS UNABLE TO CONFIRM THE REPORTED EVENT, THE TISSUE PAD IN THE GRASPING SECTION WAS WORN AWAY, BUT THE PEELED OFF OF THE TISSUE PAD WAS NOT CONFIRMED. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO DEVIATIONS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. ALTHOUGH A DEFINITIVE ROOT CAUSE CANNOT BE IDENTIFIED, THE FOLLOWING STEP-BY-STEP SCENARIO LIKELY CAUSED THE EVENT: 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. 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 PTFE PAD, SUCH AS PREMATURE WEAR, BREAKAGE, DEFORMATION, AND/OR FALLING OFF INSIDE THE BODY CAVITY AND/OR PARTIAL SEPARATING.¿ ¿WHEN CUTTING OR VESSEL SEALING IS PERFORMED IN SEAL & CUT MODE, APPLY LIGHT TENSION ON THE TISSUE SO THAT USERS CAN CONFIRM THAT THEY ARE TRANSECTED. ALSO, STOP ACTIVATION IMMEDIATELY AFTER TISSUE IS TRANSECTED. OTHERWISE, THE GRASPING SECTION, THE PTFE PAD, OR THE PROBE TIP MAY BREAK AND FALL OFF, AND PARTIAL SEPARATING OF THE PTFE PAD MAY OCCUR DUE TO A LOCAL INCREASE OF TEMPERATURE CAUSED BY THE FRICTION BETWEEN PTFE 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, THE DEVICE TEFLON PAD WAS DETACHED. THERE IS NO REPORTED HARM TO ANY PATIENT.

    Description of Event or Problem · 0

    ADDENDUM FEB 23, 2023: THE PROCEDURE WAS DIAGNOSTIC LIVER RESECTION. THE DEVICE FAILED IN THE PATIENT. THE ISSUE WAS NOTED INTERMITTENTLY. THE DEVICE BROKEN PLASTIC PART FELL IN THE PATIENT AND WAS RETRIEVED. THE PROCEDURE WAS COMPLETED WITH A NEW SIMILAR DEVICE. THERE IS NO ADVERSE IMPACT OR HARM TO THE PATIENT NOR WAS ANY EXTENDED HOSPITAL STAY REQUIRED DUE TO THIS EVENT. PATIENT¿S CURRENT STATUS IS FINE. THE INTELLIGENT TISSUE MONITORING (ITM) SETTING WAS ON DURING THE PROCEDURE AS WAS THE USUAL PRACTICE. THE ITM SETTING WAS NOT CHANGED DURING THE PROCEDURE. THE USER UNDERSTANDS THAT THE CHARACTERISTIC OF ITM FUNCTIONALITY, WHICH IS THAT ITM US A SUPPORT FUNCTIONALITY AND MAY NOT NECESSARILY IDENTIFY THAT A TISSUE HAS BEEN CUT ALREADY. THE DEVICE WAS INSPECTED PRIOR TO USE WITH NO ANOMALY NOTED. USER IS A REGULAR USER OF THE DEVICE. NO OLYMPUS REPRESENTATIVE WAS PRESENT DURING THE PROCEDURE. PER THE USER, THE EVENT WAS DUE TO MANUFACTURING ISSUE. THERE WAS ALSO RISK OF INJURY TO THE PATIENT IF THE BROKEN PIECE HAD NOT BEEN FOUND AND RETRIEVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2011594 THUNDERBEAT OPEN EXTENDED JAW ULTRASONIC SURGICAL DEVICE GEI AOMORI OLYMPUS CO., LTD. TB-0920OE 29K 06 04953170343315

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown USG-400 VER. 2.00.