BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ELECTROSURGICAL GENERATOR "ESG-300"

    MDR report key: 15127989 · Received July 29, 2022

    Report

    Report Number
    9610773-2022-00306
    Event Type
    Injury
    Date Received
    July 29, 2022
    Report Date
    October 21, 2022
    Manufacturer
    OLYMPUS WINTER & IBE GMBH
    Product Code
    GEI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE SUSPECT MEDICAL DEVICE HAS NOT YET BEEN RETURNED TO OLYMPUS FOR EVALUATION/INVESTIGATION. THEREFORE, THE EXACT CAUSE OF THE PATIENT'S OUTCOME 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 #: WA90300W; BRAND NAME: ELECTROSURGICAL GENERATOR "ESG-300" WITH FOOT SWITCH; COMMON DEVICE NAME: HF-GENERATORS; 510(K): K180200; PRODUCT CODE: GEI.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: B5 - DESCRIBE EVENT OR PROBLEM. CORRECTION: H4 - DEVICE MANUFACTURER DATE. DEVICE EVALUATION: THE SUSPECT MEDICAL DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR INVESTIGATION/EVALUATION. INSTEAD AN OLYMPUS FIELD SERVICE ENGINEER (FSE) WAS ON SITE TO CHECK THE DEVICE. DURING THE INSPECTION THE FSE CONFIRMED THAT THE HF-GENERATOR IS IN STANDARD CONDITION. FURTHERMORE, THERE WERE NO REPORTS OF ANY MALFUNCTION OF THE HF GENERATOR. BASED ON THE INFORMATION AVAILABLE, THE EXACT CAUSE OF THE REPORTED PHENOMENON AND THE PATIENT¿S OUTCOME COULD NOT BE DETERMINED AND IS BEING JUDGED AS UNKNOWN. HOWEVER, UNINTENDED USE ERROR IS LIKELY. A MATERIAL OR QUALITY PROBLEM CAN BE EXCLUDED SINCE 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. THE REPORTED EVENT/INCIDENT WILL BE RECORDED FOR TRENDING AND SURVEILLANCE PURPOSES. FURTHERMORE, THE USER WILL BE INFORMED ABOUT THE INVESTIGATION RESULTS.

    Description of Event or Problem · 0

    OLYMPUS WAS INFORMED THAT DURING AN UNSPECIFIED THERAPEUTIC PROCEDURE AT AN UNKNOWN DATE, THE MUCOSA OF THE PATIENT WAS PERFORATED DUE TO FAULTY COAGULATION FUNCTION. THE PROCEDURE WAS MODIFIED TO BE ABLE TO COMPLETE IT. NO FURTHER INFORMATION WAS PROVIDED, AND THE PATIENT¿S CURRENT CONDITION IS ALSO UNKNOWN.

    Description of Event or Problem · 0

    OLYMPUS WAS INFORMED THAT DURING A THERAPEUTIC MUCOSECTOMY PROCEDURE AT AN UNKNOWN DATE, THE MUCOSA OF THE PATIENT WAS PERFORATED DUE TO FAULTY COAGULATION FUNCTION. THE PROCEDURE WAS MODIFIED TO BE ABLE TO COMPLETE IT AND THE SURGEON CLIPPED INSTEAD. HOWEVER, THE PATIENT IS DOING WELL BY NOW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2427159 ELECTROSURGICAL GENERATOR "ESG-300" HF-GENERATORS GEI OLYMPUS WINTER & IBE GMBH WA90003W

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention