BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECTROSURGICAL GENERATOR "ESG-300"

    MDR report key: 11185467 · Received January 18, 2021

    Report

    Report Number
    9610773-2021-00048
    Event Type
    Malfunction
    Date Received
    January 18, 2021
    Date of Event
    January 8, 2021
    Report Date
    September 13, 2021
    Manufacturer
    OLYMPUS WINTER & IBE GMBH
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION: THE SUSPECT MEDICAL DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION/INVESTIGATION. THEREFORE, THE EVALUATION WAS PERFORMED EXCLUSIVELY ON THE BASIS OF THE PROVIDED INFORMATION WHICH DID NOT INCLUDE THE TECHNICAL CONDITION OF THE ELECTROSURGICAL GENERATOR. THUS, THE EXACT CAUSE OF THE USER'S EXPERIENCE AND THE REPORTED PHENOMENON COULD NOT BE DETERMINED AND IS BEING JUDGED AS UNKNOWN. HOWEVER, IT IS ASSUMED THAT THE DEVICE MET ITS SPECIFICATION AT THE TIME OF THE REPORTED EVENT AND THAT THE INSUFFICIENT RESULTS ARE DUE TO INCORRECT DEVICE SETTINGS. FURTHERMORE, A MATERIAL OR QUALITY PROBLEM CAN BE EXCLUDED SINCE A MANUFACTURING AND QUALITY CONTROL REVIEW WAS PERFORMED FOR THE AFFECTED SERIAL NUMBER OF THE ELECTROSURGICAL GENERATOR WITHOUT SHOWING ANY ABNORMALITIES. THE CASE WILL BE CLOSED ON OLYMPUS SIDE AND THE USER WILL BE INFORMED ABOUT THE INVESTIGATION RESULTS.

    Description of Event or Problem · 0

    OLYMPUS WAS INFORMED THAT DURING A THERAPEUTIC COLONOSCOPY/POLYPECTOMY PROCEDURE, THE SURGEON FELT THAT THE HF GENERATOR WAS NOT FIT FOR PURPOSE AND THAT IT WAS BURNING THE TISSUE AND NOT REMOVING THE POLYP. HOWEVER, THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH THE SAME DEVICE AND THERE WAS NO SIGNIFICANT DELAY.

    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 #: WA90300W; BRAND NAME: ELECTROSURGICAL GENERATOR "ESG-300"; COMMON DEVICE NAME: HF-GENERATORS; 510(K): K180200; PRODUCT CODE: GEI.

    Description of Event or Problem · 1

    OLYMPUS WAS INFORMED THAT DURING A THERAPEUTIC COLONOSCOPY/POLYPECTOMY PROCEDURE, THE SURGEON FELT THAT THE HF GENERATOR WAS NOT FIT FOR PURPOSE AND THAT IT WAS BURNING THE TISSUE AND NOT REMOVING THE POLYP. NO FURTHER INFORMATION WAS PROVIDED, BUT THERE WAS NO REPORT THAT A MEDICAL INTERVENTION OF ANY SORT WAS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    82967 ELECTROSURGICAL GENERATOR "ESG-300" HF-GENERATORS GEI OLYMPUS WINTER & IBE GMBH WA90003W

    Patients

    Seq Age Sex Outcome Treatment
    1 OLYMPUS ARGON PLASMA COAGULATION UNIT "APU-300."