BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 8806140 · Received July 19, 2019

    Report

    Report Number
    8010047-2019-02594
    Event Type
    Malfunction
    Date Received
    July 19, 2019
    Date of Event
    June 28, 2019
    Report Date
    September 19, 2019
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    GEI
    UDI-DI
    04953170409677
    PMA / PMN Number
    K172610
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    THE SUBJECT DEVICE WAS RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) FOR EVALUATION. THE TISSUE PAD WAS NOT WORN OR MISSING. THE PROBE WAS BROKEN OFF AT 15 MM FROM THE DISTAL END. THE BROKEN TIP WAS NOT RETURNED. THERE WAS SCRATCH AROUND THE BROKEN POINT. THE FRACTURE SURFACE OF THE PROBE SHOWED THAT CRACK DEVELOPED FROM THE SCRATCH. THE COATING FOR ELECTRIC INSULATION OF THE PROBE AROUND THE SCRATCH WAS PARTIALLY MISSING. THE MANUFACTURING RECORD WAS REVIEWED AND FOUND NO IRREGULARITIES. BASED ON THE PAST SIMILAR CASES, IT WAS KNOWN THAT THE PROBE WAS CRACKED AND THE COATING FOR ELECTRIC INSULATION OF THE PROBE WAS DAMAGED WHEN THE USER ACTIVATED OUTPUT CONTACTING WITH METAL OR SOMETHING HARD OBJECT SUCH AS METAL CLIPS, STAPLER, OR OTHER INSTRUMENTS, BESIDES THE PROBE WAS BROKEN OFF WHEN THE PROBE WAS SUBJECTED TO A LOAD. THE ABOVE DEVICE HANDLING HAS BEEN WARNED IN THE INSTRUCTION MANUAL AS FOLLOWS. 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.

    Additional Manufacturer Narrative · 1

    THE SUBJECT DEVICE REFERENCED IN THIS REPORT WAS NOT RETURNED TO OLYMPUS FOR EVALUATION. THEREFORE THE EXACT CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED AT THIS TIME. A SUPPLEMENTAL REPORT WILL BE SUBMITTED, IF ADDITIONAL OR SIGNIFICANT INFORMATION BECOMES AVAILABLE AT A LATER TIME.

    Description of Event or Problem · 1

    DURING A LAPAROSCOPIC PROSTATECTOMY, THE SUBJECT DEVICE WAS USED. AFTER 5 MINUTES OF USE, THE TISSUE PAD OF THE SUBJECT DEVICE BROKE OFF INSIDE THE PATIENT. THE FRAGMENT WAS RETRIEVED. THE INTENDED PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO PATIENT INJURY REPORTED. THIS IS THE REPORT REGARDING THE FALLING OF THE TISSUE PAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    601941 THUNDERBEAT 5 MM, 35 CM, FRONT-ACTUATED GRIP TYPE S ULTRASONIC SURGICAL DEVICE GEI OLYMPUS MEDICAL SYSTEMS CORP. TB-0535FCS KR847227 04953170409677

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR