BEUDAMED
    FDA Adverse Event Death Summary report: N

    OLYMPUS THUNDERBEAT 5MM, 35CM, FRONT ACTUATE

    MDR report key: 3812370 · Received May 6, 2014

    Report

    Report Number
    2951238-2014-00205
    Event Type
    Death
    Date Received
    May 6, 2014
    Report Date
    April 25, 2014
    Manufacturer
    OLYMPUS AMERICA, INC.
    Product Code
    GEI
    PMA / PMN Number
    K111202
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE HANDPIECE WAS NOT RETURNED TO OLYMPUS FOR EVAL AS IT WAS DISCARDED. THE EXACT CAUSE OF THE USER'S EXPERIENCE COULD NOT BE CONCLUSIVELY DETERMINED AT THIS TIME. IF ADD'L INFO BECOMES AVAILABLE AT A LATER TIME, THIS REPORT WILL BE SUPPLEMENTED.

    Description of Event or Problem · 1

    OLYMPUS WAS INFORMED THAT A PATIENT EXPIRED THE NIGHT AFTER AN UNSPECIFIED THERAPEUTIC PROCEDURE. NO DEVICE OR PT ISSUES WERE NOTED DURING THE PROCEDURE. THE PATIENT'S DEATH OCCURRED MANY HOURS POST-SURGERY AND THE CAUSE IS UNK. OLYMPUS FOLLOWED UP WITH THE USER FACILITY TO OBTAIN ADD'L INFO AND WAS INFORMED THAT NO FURTHER INFO WOULD BE DISCLOSED SINCE THE AUTOPSY REPORT WAS NOT YET AVAILABLE. HOWEVER, THE PHYSICIAN SUSPECTED POST-SURGERY BLEEDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    271810 OLYMPUS THUNDERBEAT 5MM, 35CM, FRONT ACTUATE ULTRASONIC SURGICAL DEVICE GEI OLYMPUS AMERICA, INC. TB-0535FC UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Death