BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OLYMPUS THUNDERBEAT 5MM, 35CM, PISTOL GRIP

    MDR report key: 2933405 · Received December 21, 2012

    Report

    Report Number
    8010047-2012-00461
    Event Type
    Malfunction
    Date Received
    December 21, 2012
    Date of Event
    December 6, 2012
    Report Date
    December 7, 2012
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORPORATION
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUBJECT DEVICE WAS NOT RETURNED TO OLYMPUS FOR EVALUATION. THE MANUFACTURING HISTORY WAS REVIEWED, WITH NO IRREGULARITIES NOTED. BASED ON SIMILAR CASES WITH THE SAME MODEL, THE PROBE PRESUMABLY BROKE SINCE THE PROBE WAS DAMAGED BECAUSE THE PHYSICIAN ACTIVATED ULTRASOUND OUTPUT WHILE THE PROBE WAS IN CONTACT WITH METAL SUCH AS A CLIP, AND BESIDES THE PHYSICIAN CONTINUED TO USE THE DAMAGED DEVICE, THE PROBE WAS CRACKED. THE TB-0535PC INSTRUCTION MANUAL ALREADY STATES; WARNING: DO NOT ACTIVATE OUTPUT WHILE GRASPING HARD TISSUE SUCH AS BONE OR HIGHLY CALCIFIED TISSUE, OR HARD OBJECTS SUCH AS METAL CLIPS OR OTHER INSTRUMENTS (E.Q., UTERINE MANIPULATOR). DO NOT APPLY ONLY THE PROBE TIP TO THE TISSUE WITH A STRONG FORCE, TWIST WHILE GRASPING THE TISSUE OR, PULL THE PROBE TIP UP GRASPING THE TISSUE. OTHERWISE, IT MAY CAUSE THE PROBE TO BREAK PRIOR TO AN ERROR WINDOW OR ALARM TONE BEING GENERATED. IF ADDITIONAL INFORMATION IS RECEIVED, THIS REPORT WILL BE SUPPLEMENTED. THIS REPORT IS BEING SUBMITTED AS A MEDICAL DEVICE REPORT IN AN ABUNDANCE OF CAUTION.

    Description of Event or Problem · 1

    WHEN A PHYSICIAN USED THE SUBJECT DEVICE FOR A PROCEDURE, THE PROBE BROKE. THE BROKEN PIECE OF THE PROBE WAS TAKEN OUT. THE PHYSICIAN REPLACED THE SUBJECT DEVICE WITH A DIFFERENT UNIT OF SAME MODEL. THERE WAS NO PATIENT HARM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OLYMPUS THUNDERBEAT 5MM, 35CM, PISTOL GRIP THUNDERBEAT HANDPIECE GEI OLYMPUS MEDICAL SYSTEMS CORPORATION TB-0535PC 25K

    Patients

    Seq Age Sex Outcome Treatment
    1