BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OLYMPUS THUNDERBEAT 5 MM, 35 C M, PISTOL GRIP

    MDR report key: 2990240 · Received February 7, 2013

    Report

    Report Number
    8010047-2013-00040
    Event Type
    Malfunction
    Date Received
    February 7, 2013
    Date of Event
    December 12, 2012
    Report Date
    January 9, 2013
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORPORATION
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    OLYMPUS FOLLOWED UP WITH THE REPORTER TO OBTAIN MORE INFO REGARDING THIS REPORT BUT THERE WAS NO FURTHER INFO PROVIDED. THE SUBJECT DEVICE WAS NOT RETURNED TO OLYMPUS FOR EVALUATION. THE EXACT CAUSE OF THE USER'S EXPERIENCE COULD NOT BE CONCLUSIVELY DETERMINED AT THIS TIME. IF ADDITIONAL INFO BECOMES AVAILABLE AT A LATER TIME, THIS REPORT WILL BE SUPPLEMENTED.

    Description of Event or Problem · 1

    OLYMPUS WAS INFORMED THAT DURING A TOTAL LAPAROSCOPIC HYSTERECTOMY, THE USER WAS AMPUTATING THE UTERUS AND TOOK A HUGE BITE OF THE TISSUE CAUSING THE PROBE ON THE THUNDERBEAT HANDPIECE TO BREAK OFF. THE PROBE PIECE WAS RETRIEVED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT BUT SIMILAR DEVICE. THERE WAS NO PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    51816 OLYMPUS THUNDERBEAT 5 MM, 35 C M, PISTOL GRIP THUNDERBEAT HANDPIECE GEI OLYMPUS MEDICAL SYSTEMS CORPORATION TB-0535PC UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK