BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THUNDERBEAT OPEN EXTENDED JAW

    MDR report key: 17913948 · Received October 11, 2023

    Report

    Report Number
    9614641-2023-01504
    Event Type
    Injury
    Date Received
    October 11, 2023
    Date of Event
    September 6, 2023
    Report Date
    December 4, 2023
    Manufacturer
    AOMORI OLYMPUS CO., LTD.
    Product Code
    GEI
    UDI-DI
    04953170343315
    PMA / PMN Number
    K211838
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER
    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 CORRECTION TO THE INITIAL WITH INFORMATION INADVERTENTLY LEFT OUT. ADDITIONALLY, TO PROVIDE INFORMATION RECEIVED ((B)(6)). THE SUBJECT DEVICE WAS MANUFACTURED IN NOVEMBER 2022, BUT THE SPECIFIC DATE IS UNKNOWN. THE VERSION OF THE SOFTWARE WAS VER. 2.00. THE SETTING OF INTELLIGENT TISSUE MONITORING (ITM) WAS "ON" AND THE SETTING OF ITM IS USUALLY "ON". THE USER UNDERSTOOD THE ITM CLEARLY. THE USER DID NOT CHANGE THE SETTING OF ITM DURING THE PROCEDURE. THE DEVICE WAS USED 2 HOURS DURING THE PROCEDURE. 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 REPORTED EVENT OCCURRED DUE TO THE CONTINUOUS OUTPUT OF THE DEVICE, THE GRASPING PORTION BECAME HOT. HOWEVER, THE SUBJECT DEVICE WAS NOT RETURNED THEREFORE, A SPECIFIC ROOT CAUSE COULD NOT BE DETERMINED. THE EVENT CAN BE PREVENTED BY FOLLOWING THE INSTRUCTIONS FOR USE WHICH STATE: "TO SEAL ADJACENT TISSUE, OVERLAP THE EDGE OF THE EXISTING SEAL. THE SECOND SEAL SHOULD BE DISTAL TO THE FIRST SEAL TO INCREASE SEAL MARGIN. OTHERWISE, INCOMPLETE SEALING MAY CAUSE BLEEDING AND/OR THE EXISTING SEAL MAY BE OPENED." "THE GRASPING SECTION AND PROBE TIP BECOME HOT DUE TO EXTENDED ULTRASONIC OUTPUT. DO NOT LET IT COME IN CONTACT WITH TISSUES OTHER THAN THE TARGET TISSUE." OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED TO OLYMPUS FOR EVALUATION. THE INVESTIGATION IS ONGOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 0

    THE PADDLE REFERS TO THE PROBE AND GRASP. IT IS UNCLEAR WHICH PART OF THE SHAFT TOUCHED THE PATIENT. THE ENTIRE SHAFT WAS HOT.

    Description of Event or Problem · 0

    A USER FACILITY INITIALLY REPORTED THAT THERE WAS AN INTERFACE ERROR. IT WAS ALSO REPORTED THERE WAS A 3 X 2 CM THIRD DEGREE BURN (INITIALLY STATED TO BE A SECOND DEGREE BURN) ON THE PATIENT'S ANUS FROM THE CONTACT OF THE SHAFT OF THUNDERBEAT OPEN EXTENDED JAW. THE PATIENT WAS POSITIONED IN LITHOTOMY FOR THE THERAPEUTIC COLORECTAL SURGERY FOR HEMORRHOIDS. THE ENERGY OF THE DEVICE WAS TRANSMITTED THROUGH THE PADDLES AFTER USING THE DEVICE FOR TWO HOURS AS WELL AS THROUGH THE ENTIRE 20 CENTIMETER METAL SHAFT RESULTING IN A DAMAGED SHAFT FROM THE HEAT. THE PROCEDURE WAS COMPLETED WITH THE SAME DEVICE. THE BURN WAS FOUND AT THE END OF THE SURGERY; THEREFORE, THERE WAS NO DELAY OR EXTENDED ANESTHESIA. INITIAL INFORMATION INDICATED THAT PLASTIC SURGERY MAY HAVE BEEN REQUIRED BUT THIS WAS UNABLE TO BE CONFIRMED. SILVADENE WAS PROVIDED AND THE PATIENT'S BURN WAS REPORTED TO BE CURED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2084156 THUNDERBEAT OPEN EXTENDED JAW ULTRASONIC SURGICAL DEVICE GEI AOMORI OLYMPUS CO., LTD. TB-0920OE 2JB252 04953170343315

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention