BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THUNDERBEAT OPEN FINE JAW

    MDR report key: 12443662 · Received September 8, 2021

    Report

    Report Number
    8010047-2021-11458
    Event Type
    Malfunction
    Date Received
    September 8, 2021
    Date of Event
    August 19, 2021
    Report Date
    September 9, 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
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE SUBJECT DEVICE WAS RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) FOR EVALUATION. THE PROBE WAS BROKEN OFF AT 17 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 THE PROCEDURE FOR HEAD AND NECK CANCER USING THE SUBJECT DEVICE, THE FOLLOWING EVENT OCCURRED. THE PROBE WAS BROKEN OFF. 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
    1339629 THUNDERBEAT OPEN FINE JAW ULTRASONIC SURGICAL DEVICE GEI OLYMPUS MEDICAL SYSTEMS CORP. TB-0009OF 16K

    Patients

    Seq Age Sex Outcome Treatment
    1