BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OLYMPUS THUNDERBEAT 5MM, 35CM, PISTOL GRIP

    MDR report key: 3162597 · Received February 16, 2013

    Report

    Report Number
    8010047-2013-00028
    Event Type
    Malfunction
    Date Received
    February 16, 2013
    Date of Event
    January 18, 2013
    Report Date
    January 21, 2013
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORPORATION
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUBJECT DEVICE WAS NOT RETURNED TO OLYMPUS MEDICAL SYSTEMS CORPORATION (OMSC) FOR EVALUATION. THE MANUFACTURING HISTORY WAS REVIEWED, WITH NO IRREGULARITIES NOTED. BASED ON THE REPORT BY OLYMPUS (B)(4) AND PAST SIMILAR CASES, IT IS POSSIBLE THAT SINCE THE DEVICE WAS KEPT ACTIVATED WHILE NOTHING WAS GRASPED IN THE GRASPING SECTION, THE PTFE PAD AND PROBE BECAME HOT, THE PTFE PAD WAS DEFORMED, AND PART OF THE DISTAL END OF THE PAD SEPARATED. THE INSTRUCTION MANUAL OF THUNDERBEAT MENTIONS WARNING AND CAUTION FOR POSSIBLE MISHANDLING MENTIONED ABOVE. DO NOT ACTIVATE OUTPUT FOR AN EXTENDED PERIOD WHILE THE GRASPING SECTION IS CLOSED WITHOUT CONTACTING TISSUE. OTHERWISE, A LOCAL INCREASE OF THE TEMPERATURE BETWEEN THE GRASPING SECTION DURING THE SEAL AND CUT MODE MAY RESULT IN PREMATURE WEAR, BREAKAGE AND/OR PROBE 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 THE PHYSICIAN USED THE SUBJECT DEVICE IN A LAPAROSCOPY PROXIMAL GASTRECTOMY, THE PHYSICIAN NOTICED THE ABNORMALITY OF THE PTFE PAD OF THE SUBJECT DEVICE. THE PHYSICIAN REMOVED THE SUBJECT DEVICE FROM PATIENT AND CHECKED IT. THE PHYSICIAN FOUND THAT PTFE PAD PARTIALLY SEPARATED FROM THE GRASPING SECTION. THE PHYSICIAN ENSURED THAT NO PIECE OF THE PAD FELL OFF IN THE PATIENT'S BODY. THE INTENDED PROCEDURE WAS COMPLETED WITH A NEW THUNDERBEAT. THERE WAS NO PATIENT HARM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    70224 OLYMPUS THUNDERBEAT 5MM, 35CM, PISTOL GRIP THUNDERBEAT HANDPIECE GEI OLYMPUS MEDICAL SYSTEMS CORPORATION TB-0535PC 23K

    Patients

    Seq Age Sex Outcome Treatment
    1