BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 13051102 · Received December 21, 2021

    Report

    Report Number
    8010047-2021-16509
    Event Type
    Malfunction
    Date Received
    December 21, 2021
    Date of Event
    November 30, 2021
    Report Date
    December 21, 2021
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    GEI
    PMA / PMN Number
    K211838
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE SUBJECT DEVICE WAS RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) FOR EVALUATION. THE PROBE WAS BROKEN OFF AT 15 MM FROM THE DISTAL END. THERE WAS SCRATCH AROUND THE BROKEN POINT. THE FRACTURE SURFACE OF THE PROBE SHOWED THAT CRACK DEVELOPED. THE MANUFACTURING RECORD WAS REVIEWED AND FOUND NO IRREGULARITIES. BASED ON THE PAST SIMILAR CASES, IT WAS KNOWN THAT THE PROBE WAS CRACKED 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 WARNED IN THE INSTRUCTION MANUAL.

    Description of Event or Problem · 0

    OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) WAS INFORMED BY THE HEALTH PROFESSIONAL THAT DURING A TOTAL LAPAROSCOPIC HYSTERECTOMY USING THE SUBJECT DEVICE, THE FOLLOWING EVENT OCCURRED. ULTRASONIC LEVEL ERROR OCCURRED WHEN THE USER MADE AN INCISION IN THE VAGINA. THE PROBE WAS BROKEN OFF OUTSIDE THE PATIENT WHEN THE USER REMOVE THE DEVICE FROM THE PATIENT. THE INTENDED PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1955509 THUNDERBEAT 5 MM, 35 CM, FRONT-ACTUATED GRIP TYPE S ULTRASONIC SURGICAL DEVICE GEI OLYMPUS MEDICAL SYSTEMS CORP. TB-0535FCS 18K

    Patients

    Seq Age Sex Outcome Treatment
    1 Female