BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ELECTROSURGICAL GENERATOR "ESG-300"

    MDR report key: 15922776 · Received December 6, 2022

    Report

    Report Number
    9610773-2022-00587
    Event Type
    Injury
    Date Received
    December 6, 2022
    Report Date
    June 26, 2024
    Manufacturer
    OLYMPUS WINTER & IBE GMBH BERLIN FACILITY
    Product Code
    GEI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NO
    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"; COMMON DEVICE NAME: HF-GENERATORS; 510(K): K180200; PRODUCT CODE: GEI.

    Additional Manufacturer Narrative · 0

    THE SUSPECT MEDICAL DEVICE WAS RETURNED, TO THE MANUFACTURER FOR INVESTIGATION/EVALUATION. THE EVALUATION/INVESTIGATION CONFIRMED, THAT THE RETURNED 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, 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.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED TO CORRECT THE LEGAL MANUFACTURER¿S CONTACT INFORMATION AND FACILITY REGISTRATION NUMBER. THE FACILITY REGISTRATION NUMBER IS 3003724334.

    Description of Event or Problem · 0

    OLYMPUS WAS INFORMED THAT DURING A THERAPEUTIC ANGIODYSPLASIAS IN THE CECUM PROCEDURE AT AN UNKNOWN DATE, THE PATIENT SUSTAINED A PERFORATION WHICH WAS NOT DISCOVERED UNTIL THE FOLLOWING DAY WHEN THE PATIENT RETURNED TO THE HOSPITAL. IT WAS REPORTED THAT EVERYTHING SEEMED TO BE FINE AFTER THE INITIAL PROCEDURE. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2124696 ELECTROSURGICAL GENERATOR "ESG-300" HF-GENERATORS GEI OLYMPUS WINTER & IBE GMBH BERLIN FACILITY WA90003W

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention OLYMPUS ARGON PLASMA UNIT "APU-300"| UNSPECIFIED PCF SCOPE