BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THUNDERBEAT ELECTROSURGICAL UNIT

    MDR report key: 8605089 · Received May 10, 2019

    Report

    Report Number
    MW5086584
    Event Type
    Injury
    Date Received
    May 10, 2019
    Date of Event
    April 25, 2019
    Report Date
    May 8, 2019
    Manufacturer
    OLYMPUS SURGICAL TECHNOLOGIES AMERICA
    Product Code
    GEI
    UDI-DI
    04953170337574
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2019, A CASE WAS BEING CONDUCTED AT (B)(6) IN (B)(6) USING AN OLYMPUS THUNDERBEAT. AS THE ELECTROSURGICAL UNIT WAS BEING USED THE ACTIVE ELECTRODE BROKE CAUSING A COMPONENT OF THE DEVICE TO DISLODGE AND BECOME TRAPPED IN THE PT. ONCE THE DEVICE REMOVED FROM THE PT, IT WAS NOTICED THAT THE ACTIVE ELECTRODE HAD BECOME DISCOLORED (BLACKENED) WHERE THE COMPONENT HAD BROKEN OFF. THERE WAS NO HARM TO THE PT AND THE CASE WAS COMPLETED. I REPORTED THIS TO OLYMPUS DIRECTLY AND FILED A REPORT WITH OUR RISK MANAGER HERE. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    395578 THUNDERBEAT ELECTROSURGICAL UNIT ELECTROSURGICAL , CUTTING AND COAGULATION AND ACCESSORIES GEI OLYMPUS SURGICAL TECHNOLOGIES AMERICA TB-0535FC KR824648 04953170337574

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention