BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OLYMPUS THUNDERBEAT 5MM, 35CM, PISTOL GRIP

    MDR report key: 2927786 · Received December 18, 2012

    Report

    Report Number
    8010047-2012-00457
    Event Type
    Malfunction
    Date Received
    December 18, 2012
    Date of Event
    November 20, 2012
    Report Date
    December 25, 2015
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORPORATION
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    OTHER

    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 14 MM FROM THE DISTAL END AND THAT WAS NOT RETURNED TO OMSC. AND A SCRATCH MARK OF THE PROBE WAS FOUND. THE MANUFACTURING HISTORY WAS REVIEWED, WITH NO IRREGULARITIES NOTED. BASED ON THE ANALYSIS RESULT OF THE SUBJECT DEVICE, 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 CLIP, AND BESIDES THE PHYSICIAN CONTINUED TO USE THE DAMAGED DEVICE, THE PROBE WAS CRACKED. THE (B)(4) 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.G., 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.

    Additional Manufacturer Narrative · 1

    OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) PERFORMED A MDR RETROSPECTIVE REVIEW AND FOUND THAT THIS SUPPLEMENTAL REPORT THAT THIS SUPPLEMENTAL REPORT IS REQUIRED ON DECEMBER 14TH, 2015. THIS IS A SUPPLEMENTAL REPORT FOR MFR REPORT # 8010047-2012-00457 TO CORRECT THE EVALUATION RESULT. BASED ON THE EVALUATION OF THE RETURNED DEVICE. THE SUBJECT DEVICE AND THE FRAGMENT OF PROBE WERE RETURNED TO OLYMPUS MEDICAL SYSTEMS CORPORATION (OMSC) FOR EVALUATION. THE EVALUATION CONFIRMED THAT THE PROBE BROKE DOWN AT 16.5 MM FROM THE DISTAL END. AND A SCRATCH MARK OF THE PROBE WAS FOUND. THE MANUFACTURING HISTORY WAS REVIEWED, WITH NO IRREGULARITIES NOTED. BASED ON THE ANALYSIS RESULT OF THE SUBJECT DEVICE, 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 (B)(4) 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. THIS TYPE OF THE PTFE DAMAGE IS MOST LIKELY RELATED TO THE OPERATOR'S TECHNIQUE.

    Description of Event or Problem · 1

    WHEN A PHYSICIAN USED THE SUBJECT DEVICE FOR A LAPAROSCOPIC COLECTOMY PROCEDURE, THE PROBE BROKE AND FELL OFF INSIDE THE PT'S BODY. THE PHYSICIAN REPLACED THE SUBJECT DEVICE WITH A DIFFERENT UNIT OF SAME MODEL. THE PROCEDURE WAS COMPLETED AS SCHEDULED. THE BROKEN PIECE OF THE PROBE WAS TAKEN OUT FROM THE PT'S BODY. THERE WAS NO PT 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 22K

    Patients

    Seq Age Sex Outcome Treatment
    1