BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THUNDERBEAT 5 MM, 35 CM, PISTOL GRIP

    MDR report key: 13257306 · Received January 14, 2022

    Report

    Report Number
    8010047-2022-01452
    Event Type
    Malfunction
    Date Received
    January 14, 2022
    Date of Event
    May 21, 2021
    Report Date
    April 5, 2022
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    GEI
    UDI-DI
    04953170308659
    PMA / PMN Number
    K132703
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THERE ARE TWO EVENTS REPORTED FOR THIS DEVICE FOR THE SAME ISSUE. THESE EVENTS ARE CAPTURED IN MEDWATCHES WITH PATIENT IDENTIFIERS (B)(6) (EVENT DATE (B)(6) 2021) AND (B)(6) (EVENT DATE (B)(6) 2021). THIS MEDWATCH IS FOR THE PATIENT IDENTIFIER (B)(6). THE DEVICE IS RETURNED BUT THE DEVICE EVALUATION IS NOT YET COMPLETED. AS SUCH A DEFINITIVE ROOT CAUSE OF THE REPORTED COMPLAINT CANNOT BE DETERMINED AT THIS TIME. SUPPLEMENTAL REPORT(S) WILL BE FILED AS THE INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE LEGAL MANUFACTURER'S FINAL INVESTIGATION AND CORRECTION TO D9. D9 - CORRECTED PRODUCT RECEIPT DATE. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO DEVIATIONS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. THE SPECIFIC ROOT CAUSE OF THE EVENT COULDN¿T BE EXCLUSIVELY IDENTIFIED. HOWEVER BASED ON THE INVESTIGATION RESULTS, THE REPORTED EVENT POSSIBLY OCCURRED BY THE FOLLOWING MECHANISM: 1)THE PROBE CAME INTO CONTACT WITH A METAL OBJECT OR SURGICAL INSTRUMENTS WHILE THE OUTPUT WAS ACTIVATING IN SEAL & CUT MODE. 2)THE PROBE RECEIVED AN OUTPUT LOAD IN SEAL & CUT MODE OR RECEIVED A LOAD WHEN GRASPING TISSUE. AS A RESULT, THE PROBE CRACKED FROM THE SCRATCH. 3)THE PROBE BROKE WHEN ADDED SOME LOAD. THE FOLLOWING INFORMATION IS STATED IN THE INSTRUCTIONS FOR USE WHICH MAY HAVE PREVENTED THE EVENT: "THE THUNDERBEAT INSTRUMENT SHOULD BE USED FOR SOFT TISSUE. DO NOT ACTIVATE OUTPUT WHILE GRASPING HARD TISSUE SUCH AS BONE OR HIGHLY CALCIFIED TISSUE, OR HARD OBJECTS SUCH AS METAL CLIPS, STAPLER, OR OTHER INSTRUMENTS (E.G., UTERINE MANIPULATOR, FORCEPS, AND OTHERS). OTHERWISE, IT MAY CAUSE THE PROBE TIP TO BE SCRATCHED OR COME INTO DIRECT CONTACT WITH THE METAL AREA OF THE GRASPING SECTION AS THE HEAT GENERATED BY THE FRICTION BETWEEN THE HARD OBJECT AND THE PROBE TIP COULD CAUSE WEAR/DEFORMING/SPLITTING/PROTRUDING/PARTIAL SEPARATING OF THE TISSUE PAD. IN TURN, THE PROBE MAY BREAK BEFORE DISPLAYING AN ERROR WINDOW OR GENERATING AN ALARM TONE. 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

    AS REPORTED FOR THIS EVENT, DURING A THERAPEUTIC LAPAROSCOPIC ONCOLOGY PROCEDURE, ONE OF THE JAWS OF THE DEVICE BROKE OFF AT THE BEGINNING OF THE PROCEDURE WITH NO ERROR MESSAGES. THE BROKEN PIECE FELL INTO THE PATIENT AND WAS RETRIEVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED BY ANOTHER SIMILAR DEVICE. THE PROCEDURE COMPLETION WAS DELAYED BY 20 MINUTES. THERE WAS NO HARM OR ADVERSE IMPACT TO THE PATIENT AS A RESULT OF THIS EVENT. SETTING AT THE TIME OF THE EVENT WAS SEAL AND CUT AND SEAL. THE DEVICE IS BEING USED REGULARLY AT THE FACILITY SINCE 2010. THE INTELLIGENT TISSUE MONITORING (ITM) WAS TURNED OFF, THOUGH USUALLY THE ITM IS TURNED ON. THE USER IS FAMILIAR WITH THE FUNCTION OF THE ITM. THE DOCTOR WAS DISSATISFIED WITH THE OCCURRING OF THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    611037 THUNDERBEAT 5 MM, 35 CM, PISTOL GRIP ULTRASONIC SURGICAL DEVICE GEI OLYMPUS MEDICAL SYSTEMS CORP. TB-0535PC 01K-0JB013 04953170308659

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Female USG-400, VERSION 2.00