BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HF UNIT "ESG-400"

    MDR report key: 9835141 · Received March 16, 2020

    Report

    Report Number
    9610773-2020-00093
    Event Type
    Malfunction
    Date Received
    March 16, 2020
    Date of Event
    March 10, 2020
    Report Date
    May 11, 2021
    Manufacturer
    OLYMPUS WINTER & IBE GMBH
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE SUSPECT MEDICAL DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION/INVESTIGATION BUT TO AN OLYMPUS REGIONAL REPAIR CENTER IN JAPAN ON 2020-03-16. THE EVALUATION DID NOT CONFIRM THE OCCURRENCE OF ERROR MESSAGE E433 WHICH IS TRIGGERED BY THE GENERATOR¿S SAFETY SYSTEM. IN CASE OF CRITICAL ERRORS, THE SAFETY SYSTEM WILL NOT PERMIT ANY FURTHER USE OF THE GENERATOR UNTIL THE ERROR IS RECTIFIED. IN THE CASE AT HAND, THIS MIGHT HAVE BEEN CAUSED BY A DEFECTIVE FOOTSWITCH. SINCE THE FOOTSWITCH WAS NOT RETURNED FOR EVALUATION/INVESTIGATION THIS CANNOT BE CONFIRMED. THUS, THE EXACT CAUSE OF THE USER'S EXPERIENCE AND THE REPORTED PHENOMENON COULD NOT BE DETERMINED AND IS BEING JUDGED AS UNKNOWN. HOWEVER, A MANUFACTURING AND QUALITY CONTROL REVIEW WAS PERFORMED FOR THE AFFECTED SERIAL NUMBER OF THE HF GENERATOR WITHOUT SHOWING ANY ABNORMALITIES. THE CASE WILL BE CLOSED ON OLYMPUS SIDE WITH NO FURTHER ACTIONS BUT THE REPORTED EVENT/INCIDENT WILL BE RECORDED FOR TRENDING AND SURVEILLANCE PURPOSES. FURTHERMORE, THE USER WILL BE INFORMED ABOUT THE INVESTIGATION RESULTS.

    Additional Manufacturer Narrative · 1

    THE SUSPECT MEDICAL DEVICE HAS NOT YET BEEN RETURNED TO OLYMPUS FOR EVALUATION/INVESTIGATION. THEREFORE, THE EXACT CAUSE OF THE USER'S EXPERIENCE AND THE REPORTED PHENOMENON COULD NOT BE DETERMINED AND IS BEING JUDGED AS UNKNOWN. HOWEVER, IF THE SUSPECT MEDICAL DEVICE IS RETURNED FOR EVALUATION/INVESTIGATION OR ADDITIONAL SIGNIFICANT INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE UPDATED. PLEASE NOTE: THIS REPORT IS BEING SUBMITTED ALTHOUGH THE SUSPECT MEDICAL DEVICE IS NOT MARKETED IN THE USA. HOWEVER, A SIMILAR DEVICE IS MARKETED. MODEL # / CATALOG #: WB91051W; BRAND NAME: HF UNIT "ESG-400"; COMMON DEVICE NAME: HF-GENERATORS; 510(K): K141225; PRODUCT CODE: GEI.

    Description of Event or Problem · 1

    OLYMPUS WAS INFORMED THAT DURING INSPECTION PRIOR TO AN UNSPECIFIED PROCEDURE, IT WAS NOTICED THAT THE ESG-400 ELECTROSURGICAL GENERATOR DISPLAYED ERROR CODE E433. THE ERROR CODE DID NOT DISAPPEAR EVEN AFTER RESTARTING THE ELECTROSURGICAL GENERATOR SEVERAL TIMES. NO FURTHER INFORMATION WAS PROVIDED, BUT THERE WAS NO REPORT ABOUT AN ADVERSE EVENT OR PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    300868 HF UNIT "ESG-400" HF-GENERATORS GEI OLYMPUS WINTER & IBE GMBH WB91051J

    Patients

    Seq Age Sex Outcome Treatment
    1