BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OLYMPUS THUNDERBEAT 5MM, 20CM, INLINE GRIP

    MDR report key: 3060748 · Received March 29, 2013

    Report

    Report Number
    8010047-2013-00080
    Event Type
    Malfunction
    Date Received
    March 29, 2013
    Date of Event
    March 4, 2013
    Report Date
    March 4, 2013
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORPORATION
    Product Code
    KNS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUBJECT DEVICE WAS RETURNED TO OLYMPUS MEDICAL SYSTEMS CORPORATION (OMSC) FOR EVALUATION. THE EVALUATION CONFIRMED THAT THE PROBE BROKE DOWN AT 13 MM FROM THE DISTAL END. AND THERE WAS A SCRATCH AT THE BROKEN POINT. THERE WAS A CONTACT MARK OF THE PROBE AND JAW WHERE THE PROBE WAS BROKEN OFF. THE PTFE PAD WAS DEFORMED. THE MANUFACTURING HISTORY WAS REVIEWED, WITH NO IRREGULARITIES NOTED. BASED ON THE ANALYSIS RESULT ABOVE, SINCE THE DEVICE WAS GRASPING A THICK AND HARD TISSUE AND ACTIVATE WHILE TWISTING THE TISSUE, THE PTFE PAD UNEVENLY WORN AND THE PROBE AND JAW CAME INTO CONTACT WITH EACH OTHER SPARKS OCCURRED BETWEEN THEM: THAT CAUSED THE DEVICE A CRACK OCCURRED. THE TB-0520IC INSTRUCTION MANUAL ALREADY STATES; WARNING: DO NOT APPLY ONLY THE PROBE TIP TO THE TISSUE WITH A STRONG FORCE OR PULL THE PROBE TIP UP GRASPING A TISSUE OR ACTIVATE OUTPUT WHILE TWISTING THE SHAFT OR TURNING THE ROTATION KNOB WITH THE TRANSDUCER AND CONNECTION CABLE. OTHERWISE, THE PROBE MAY BE DAMAGED BY INTERFERENCE WITH THE INTERNAL PARTS, WHICH COULD RESULT IN THE TIP BREAKING AND DROPPING INSIDE THE BODY CAVITY. 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 OF THE SUBJECT DEVICE BROKE. THE BROKEN PIECE OF THE PROBE WAS TAKEN OUT. THE PHYSICIAN REPLACED THE SUBJECT DEVICE WITH A SIMILAR DEVICE. THE PROCEDURE WAS COMPLETED AS SCHEDULED. THERE WAS NO PATIENT HARM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    129741 OLYMPUS THUNDERBEAT 5MM, 20CM, INLINE GRIP THUNDERBEAT HANDPIECE KNS OLYMPUS MEDICAL SYSTEMS CORPORATION TB-0520IC 29K

    Patients

    Seq Age Sex Outcome Treatment
    1