BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THUNDERBEAT 5 MM, 35 CM, FRONT-ACTUATED GRIP

    MDR report key: 3811130 · Received March 24, 2014

    Report

    Report Number
    2951238-2014-00113
    Event Type
    Malfunction
    Date Received
    March 24, 2014
    Date of Event
    February 28, 2014
    Report Date
    March 4, 2014
    Manufacturer
    OLYMPUS MEDICAL SYSTEM CORP
    Product Code
    GEI
    PMA / PMN Number
    K111202
    Removal / Correction Number
    Z-0432-2014
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED TO OLYMPUS FOR EVAL. 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 LAPAROSCOPIC SUPRACERVICAL HYSTERECTOMY (LSH) PROCEDURE, THE TIP OF THUNDERBEAT PROBE BROKE OFF INSIDE THE PT, BUT THE PHYSICIAN WAS ABLE TO RETRIEVE BROKEN PROBE TIP. A SECOND THUNDERBEAT WAS USED AND THE PROCEDURE WAS COMPLETED. THERE WAS NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    172774 THUNDERBEAT 5 MM, 35 CM, FRONT-ACTUATED GRIP ULTRASONIC SURGICAL DEVICE GEI OLYMPUS MEDICAL SYSTEM CORP TB-0535FC UNK

    Patients

    Seq Age Sex Outcome Treatment
    1