BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ELECTROSURGICAL GENERATOR "ESG-300"

    MDR report key: 9848232 · Received March 18, 2020

    Report

    Report Number
    9610773-2020-00094
    Event Type
    Injury
    Date Received
    March 18, 2020
    Date of Event
    March 6, 2020
    Report Date
    March 18, 2020
    Manufacturer
    OLYMPUS WINTER & IBE GMBH
    Product Code
    GEI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUSPECT MEDICAL DEVICE WAS NOT RETURNED TO OLYMPUS FOR EVALUATION/INVESTIGATION. THEREFORE, THE EVALUATION WAS PERFORMED EXCLUSIVELY ON THE BASIS OF THE INFORMATION PROVIDED BY THE CUSTOMER. THERE WERE NO REPORTS OF ANY MALFUNCTION OF THE 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. 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 ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD) IN THE COLON PROCEDURE, THE PATIENT SUSTAINED A PERFORATION OF THE COLON. THE INTENDED PROCEDURE WAS CANCELLED AND CONVERTED TO OPEN SURGERY. NO FURTHER INFORMATION WAS PROVIDED, BUT THERE WAS NO REPORT ABOUT A MALFUNCTION OF THE OLYMPUS MEDICAL DEVICES. ALSO, IT WAS REPORTED THAT THE PATIENT HAD WEAK TISSUE DUE TO STEROID MEDICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310338 ELECTROSURGICAL GENERATOR "ESG-300" HF-GENERATORS GEI OLYMPUS WINTER & IBE GMBH WA90003J

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention