BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OLYMPUS THUNDERBEAT 5 MM, 35 CM, PISTOL GRIP

    MDR report key: 2864605 · Received November 8, 2012

    Report

    Report Number
    8010047-2012-00432
    Event Type
    Malfunction
    Date Received
    November 8, 2012
    Date of Event
    October 12, 2012
    Report Date
    October 12, 2012
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    OLYMPUS FOLLOWED-UP WITH THE SALES REP TO OBTAIN ADDITIONAL INFO. THE SALES REP REPORTED THAT THE PROBE OF THE SECOND THUNDERBEAT HANDPIECE BROKE OFF IN THE MIDDLE AND IT WAS IN ONE PIECE. THE DETACHED FRAGMENT WAS SAID TO HAVE BEEN RETRIEVED WITH A LAPAROSCOPIC GRASPER. THE USERS REPORTEDLY WERE DISSECTING AN UTERINE SUSPENSION LITIGATION WHEN THE PROBE BROKE OFF. THE DEVICES REFERENCED IN THIS REPORT WHERE RETURNED TO OLYMPUS FOR EVAL. THE FIRST THUNDERBEAT HANDPIECE FAILED THE PROBE CHECK WITH AN ERROR CODE U509. VISUAL INSPECTION OF THE DEVICE NOTED A FRACTURE NEAR THE PROXIMAL END. THE TEFLON PAD WAS MELTED AT THE CENTER. THERE WERE TISSUE BUILDUPS ON THE PROBE AND ON THE JAW. THERE WAS RESTRICTION NOTED ON THE WIPER MOVEMENT DUE TO TISSUE BUILDUP ON THE JAW. THE SECOND THUNDERBEAT HANDPIECE FAILED THE PROBE CHECK WITH AN ERROR CODE U509 AS WELL. THE PROBE WAS BROKEN AT THE PROXIMAL END AND THE BROKEN TIP WAS ALSO RETURNED. THE BROKEN TIP AND THE JAW WERE FOUND WITH MINOR TISSUE BUILDUP. THE TEFLON PAD WAS MELTED AT THE CENTER AND AT THE TIP. THE WIPER MOVEMENT WAS NOTED WITH SLIGHT RESTRICTION DUE TO TISSUE BUILDUP. THE CONSISTENCY MOVEMENT OF THE HANDLE AND THE JAW OF BOTH RETURNED HANDPIECES WERE FINE. ADDITIONALLY, THE HANDLE LOAD, ROTATION OF KNOB TORQUE, AND SWITCH FUNCTION OF THE TWO RETURNED HANDPIECES WERE FOUND WITHOUT ANY ISSUES. BOTH DEVICES HAD BEEN FORWARDED TO THE ORIGINAL EQUIPMENT MFR FOR FURTHER EVAL. THIS REPORT IS BEING SUBMITTED AS A MEDICAL DEVICE REPORT IN AN ABUNDANCE OF CAUTION.

    Description of Event or Problem · 1

    OLYMPUS WAS INFORMED THAT DURING A LAPAROSCOPIC SUPRACERVICAL HYSTERECTOMY (LSH) PROCEDURE, THE FIRST THUNDERBEAT HANDPIECE WAS CONTINUOUSLY GENERATING UNSPECIFIED ERROR CODES AND THE TRANSDUCER WAS SAID TO HAVE BEEN REPLACED AS A RESULT, BUT, THE ERROR CODES PERSISTED. THE USERS REPORTEDLY SWITCHED TO ANOTHER THUNDERBEAT HANDPIECE OF WHICH THE TIP OF THE PROBE WAS SAID TO HAVE BEEN BROKE OFF IN THE PT. THE BROKEN FRAGMENT REPORTEDLY WAS RETRIEVED. THE INTENDED PROCEDURE WAS SAID TO HAVE BEEN COMPLETED WITH A THIRD THUNDERBEAT HANDPIECE. THERE WAS NO PT HARM REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 OLYMPUS TB-0535PC WITH LOT # 23K| OLYMPUS ESG-400 WITH SERIAL NUMBER (B)(4)| USG-400 WITH SERIAL NUMBER (B)(4)