BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 16364559 · Received February 13, 2023

    Report

    Report Number
    9614641-2023-00210
    Event Type
    Malfunction
    Date Received
    February 13, 2023
    Date of Event
    November 9, 2022
    Report Date
    February 13, 2023
    Manufacturer
    AOMORI OLYMPUS CO., LTD.
    Product Code
    GEI
    UDI-DI
    04953170383557
    PMA / PMN Number
    K211838
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    DURING INSPECTION AND TESTING, THE PROBE WAS FOUND TO BE BROKEN OFF AT THE PROXIMAL END AROUND THE OUTER PIPE. THE BROKEN SURFACE STARTED AT A CRACKED AREA OF THE PROBE. THE BROKEN PIECE WAS NOT RETURNED. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO DEVIATIONS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE BROKEN PROBE. THE DEVICE SHIPPED ACCORDING TO SPECIFICATIONS. BASED ON THE RESULTS OF THE LEGAL MANUFACTURER'S INVESTIGATION, IT IS LIKELY THE ERROR OCCURRED AND THE PROBE BROKE BECAUSE DURING OUTPUT IN SEAL AND CUT MODE, THE DISTAL END OF THE PROBE WAS IN CONTACT WITH A DEVICE WITH A THIN TIP CAUSING SPARK GENERATION AND A FORCE WAS APPLIED DURING SPARK GENERATION. A FORCE TO GRASP TISSUE OR A FORCE TO ACTIVATE OUTPUT IN SEAL AND CUT MODE WAS THEN APPLIED TO THE PROBE WHICH GENERATED CRACKS ON THE PROBE AND THE PROBE DAMAGE ERROR OCCURRED. DUE TO CONTINUED USE OF THE DEVICE, THE CRACKS ON THE PROBE PROGRESSED LEADING TO BREAKAGE OF THE PROBE. HOWEVER, A DEFINITIVE ROOT CAUSE OF THE REPORTED ISSUE COULD NOT BE IDENTIFIED. THE DEVICE'S INSTRUCTION MANUAL PROVIDES THE FOLLOWING WARNING, WHICH MAY HELP TO PREVENT THE ISSUE: "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." "IF THE GRASPING SECTION, METAL-EXPOSED AREA AROUND IT OR THE PROBE TIP GETS STICKED TISSUE DURING TREATMENT, WIPE IT WITH A SOFT OBJECT SUCH AS A PIECE OF GAUZE OR A BRUSH. DO NOT ATTEMPT TO SCRAPE IT WITH A SHARP OBJECT SUCH AS A SCALPEL OR THE TIP OF TWEEZERS. OTHERWISE, THE GRASPING SECTION, METAL-EXPOSED AREA AROUND IT, THE FLUORINE RESIN PART, A COATED SURFACE OR THE PROBE TIP MAY BE SCRATCHED AND DAMAGED, WHICH MAY LEAD TO FALL-OFF OF THE DAMAGED PART INTO THE BODY CAVITY OR BURNS OF THE TISSUE BY A HIGH-FREQUENCY LEAK CURRENT OUTPUT DUE TO DESTRUCTION OF THE INSULATION STRUCTURE." OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE. IN ADDITION, THE COATING OF THE GRASPING SECTION WAS PARTIALLY PEELED OFF, POSSIBLY DUE TO DIRT BEING SCRAPED OFF WITH SOMETHING HARD. PER THE LEGAL MANUFACTURER, THIS DEVICE DEFECT HAS NO POTENTIAL TO CAUSE OR CONTRIBUTE TO DEATH OR SERIOUS INJURY IF THE MALFUNCTION WERE TO RECUR.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT, DURING A LAPAROSCOPY SURGERY, TWO HANDPIECES DID NOT WORK AND ERROR MESSAGE U504 WAS DISPLAYED ON THE GENERATOR WHEN BOTH WERE IN USE. THE JAWS OF THE DEVICE WITH LOT NUMBER KR233199 BROKE OFF, OUTSIDE OF THE PATIENT, WHEN IT WAS PLACED ON THE TABLE. THE PROCEDURE WAS COMPLETED WITH A THIRD SIMILAR DEVICE AND THERE WAS NO IMPACT ON THE PATIENT DUE TO THE EVENT. THE SUBJECT DEVICE WAS SENT TO OLYMPUS FOR EVALUATION. DURING INSPECTION AND TESTING, THE PROBE WAS FOUND TO BE BROKEN OFF. THIS REPORT IS BEING SUBMITTED FOR THE MALFUNCTION FOUND DURING EVALUATION (BROKEN PROBE). THIS REPORT IS FOR THE SECOND HANDPIECE (LOT KR233199). THE FIRST HANDPIECE (LOT KR227559) IS BEING REPORTED ON THE MEDWATCH WITH PATIENT IDENTIFIER (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1653669 THUNDERBEAT 5 MM, 35 CM, FRONT-ACTUATED GRIP TYPE S ULTRASONIC SURGICAL DEVICE GEI AOMORI OLYMPUS CO., LTD. TB-0535FCS KR233199 04953170383557

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown