BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OLYMPUS THUNDERBEAT 5MM, 45CM, PISTOL GRIP

    MDR report key: 3060746 · Received March 29, 2013

    Report

    Report Number
    8010047-2013-00060
    Event Type
    Malfunction
    Date Received
    March 29, 2013
    Date of Event
    February 27, 2013
    Report Date
    March 4, 2013
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORPORATION
    Product Code
    GEI
    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 9.5 MM FROM THE DISTAL END. AND THERE WAS A SCRATCH AT THE BROKEN POINT. THERE WAS A CONTACT MARK OF THE PROBE AND GRASPING SECTION WHERE THE PROBE WAS BROKEN OFF. THE SHAPE OF THE FRACTURE SURFACE SHOWED THAT THE FRACTURE DEVELOPED FROM THE SCRATCHED AS THE STARTING POINT. 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 PROBE AND GRASPING SECTION CAME INTO CONTACT WITH EACH OTHER SPARKS OCCURRED BETWEEN THEM. THAT CAUSED THE DEVICE A SCRATCH OCCURRED. AFTER THAT, SINCE THE PHYSICIAN CONTINUED TO USE THE DEVICE, THE PROBE TIP BROKE. THE TB-0545PC 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 RESECTION OF SIGMOID, THE PHYSICIAN DETECTED THE BROKEN PROBE BY LAPAROSCOPIC IMAGE. THE BROKEN PIECE OF THE PROBE WAS TAKEN OUT. THE PHYSICIAN REPLACED THE SUBJECT DEVICE WITH A SIMILAR DEVICE. THERE WAS NO PATIENT HARM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    131263 OLYMPUS THUNDERBEAT 5MM, 45CM, PISTOL GRIP THUNDERBEAT HANDPIECE GEI OLYMPUS MEDICAL SYSTEMS CORPORATION TB-0545PC 22K

    Patients

    Seq Age Sex Outcome Treatment
    1