BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 18812948 · Received February 29, 2024

    Report

    Report Number
    9614641-2024-00533
    Event Type
    Injury
    Date Received
    February 29, 2024
    Date of Event
    January 31, 2024
    Report Date
    May 6, 2024
    Manufacturer
    AOMORI OLYMPUS CO., LTD.
    Product Code
    GEI
    UDI-DI
    04953170383557
    PMA / PMN Number
    K211838
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED AND THE DEVICE EVALUATION IS ANTICIPATED. THE INVESTIGATION IS ONGOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE A CORRECTION TO THE INITIAL WITH INFORMATION INADVERTENTLY LEFT OUT (B5 AND G2).

    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 CORRECTION TO THE INITIAL WITH INFORMATION INADVERTENTLY LEFT OUT (B5 AND E3) AND TO PROVIDE UPDATES TO FIELDS (H3 AND H4). THE DEVICE WAS EVALUATED BY OLYMPUS. IT WAS CONFIRMED THAT THE PROBE HAD BROKEN AROUND THE OUTER PIPE. ADDITIONALLY, THERE WERE NON-REPORTABLE (NON-PAE) DEFECTS NOTED. 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, AND PAST INVESTIGATION RESULTS, IT IS LIKELY THE PROBE BROKE WHICH LED TO RECOVERY OF THE SUBJECT DEVICE OCCURRED DUE TO THE FOLLOWING MECHANISMS. 1) DURING THE OUTPUT ACTIVATION IN SEAL & CUT MODE, THE DISTAL END OF THE PROBE WAS SLIGHTLY CONTACTING A DEVICE WITH A THIN TIP, CAUSING SPARK GENERATION. 2) A FORCE WAS APPLIED TO THE PROBE DURING SPARK GENERATION. 3) A FORCE TO GRASP TISSUE OR A FORCE TO ACTIVATE THE OUTPUT IN SEAL & CUT MODE WAS APPLIED TO THE PROBE. THIS GENERATED CRACKS ON THE PROBE. 4) DUE TO CONTINUOUS USE OF THE DEVICE, THE CRACKS ON THE PROBE PROGRESSED. THIS LED TO BREAKAGE OF THE PROBE. HOWEVER, A SPECIFIC ROOT CAUSE OF THE REPORTED EVENT COULD NOT BE IDENTIFIED. THE EVENT CAN BE PREVENTED BY FOLLOWING THE INSTRUCTIONS FOR USE WHICH STATE: "DO NOT GRASP OR LET THE PROBE TIP CONTACT HARD OBJECTS SUCH AS METAL CLIPS, STAPLER, OR OTHER INSTRUMENTS (E.G., UTERINE MANIPULATOR). ALSO, BE CAREFUL TO AVOID CONTACTING THE PROBE TIP WITH THOSE ACCIDENTALLY. PARTICULARLY DURING ACTIVATION, A SCRATCH ON THE PROBE TIP COULD OCCUR DUE TO ULTRASONIC VIBRATION, WHICH LEADS THE PROBE TIP TO BREAK AND FALL OFF INTO THE BODY CAVITY. IN ADDITION, THE HIGH-FREQUENCY (RF BIPOLAR) CURRENT FLOWS THROUGH THE METAL AND GENERATES SPARK DISCHARGE, WHICH MAY CAUSE BURNS AND DECREASE FUNCTIONALITIES." OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED THE PROBE OF THE THUNDERBEAT BROKE IN THE PATIENTS' ABDOMINAL CAVITY. THE ISSUE OCCURRED DURING THE LAPAROSCOPIC PROCEDURE AND THE BROKEN PART WAS RETRIEVED. THERE WAS NO EFFECT TO THE PATIENTS' HEALTH.

    Description of Event or Problem · 0

    IT WAS REPORTED THE PROCEDURE WAS A COLOSCOPY DIGESTIVE SURGERY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PROCEDURE WAS COMPLETED WITH USE OF A SIMILAR DEVICE AND NO SUPPLEMENTAL ANESTHESIA WAS REQUIRED. THE SETTING ON INTELLIGENT TISSUE MONITORING (ITM) WAS "ON" AND THE USER UNDERSTOOD ITM CLEARLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290475 THUNDERBEAT 5 MM, 35 CM, FRONT-ACTUATED GRIP TYPE S ULTRASONIC SURGICAL DEVICE GEI AOMORI OLYMPUS CO., LTD. TB-0535FCS KR401085 04953170383557

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention