BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OLYMPUS GENERATOR

    MDR report key: 23467943 · Received November 4, 2025

    Report

    Report Number
    MW5178506
    Event Type
    Malfunction
    Date Received
    November 4, 2025
    Report Date
    October 28, 2025
    Manufacturer
    OLYMPUS SURGICAL TECHNOLOGIES AMERICA
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    UNKNOWN
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    DESCRIPTION OF EVENT: IT WAS REPORTED THAT DURING A PROCEDURE, THE CUTTING MODE OF THE TORCH HOOK WAS WORKING SLOWER THAN USUAL. THE COAGULATION MODE WAS WORKING NORMAL. THE TORCH HOOK WAS CONNECTED TO THE PRODUCT E2450H (LOST). THE GENERATOR WAS A NON (B)(6) UNIT. THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2678494 OLYMPUS GENERATOR ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI OLYMPUS SURGICAL TECHNOLOGIES AMERICA OLYMPUS GENERATOR

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown