BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ELECTROSURGICAL GENERATOR "ESG-300"

    MDR report key: 10606280 · Received September 30, 2020

    Report

    Report Number
    9610773-2020-00230
    Event Type
    Injury
    Date Received
    September 30, 2020
    Date of Event
    September 18, 2020
    Report Date
    November 25, 2020
    Manufacturer
    OLYMPUS WINTER & IBE GMBH
    Product Code
    GEI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION: THE SUSPECT MEDICAL DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR INVESTIGATION BUT TO AN OLYMPUS REGIONAL REPAIR CENTER IN THE UNITED KINGDOM. DURING THE EVALUATION/INVESTIGATION THE AFFECTED DEVICE DID NOT SHOW ANY MALFUNCTIONS WHICH MIGHT HAVE CAUSED THE PATIENT¿S OUTCOME. THEREFORE, THE EXACT CAUSE OF THE REPORTED PHENOMENON COULD NOT BE DETERMINED AND IS BEING JUDGED AS UNKNOWN. IN ADDITION, A DETACHED FOOT SWITCH SOCKET AND CRACKS ON THE FRONT PANEL WERE DETECTED. THE CAUSE FOR THE DETACHED FOOT SWITCH SOCKET REMAINS UNCLEAR WHILE THE CAUSE FOR THE CRACKED FRONT PANEL IS VERY LIKELY IMPROPER HANDLING. 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 "ESG-300" WITHOUT SHOWING ANY ABNORMALITIES. THE CASE WILL BE CLOSED FROM 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 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.

    Description of Event or Problem · 1

    OLYMPUS WAS INFORMED THAT DURING A THERAPEUTIC POLYPECTOMY PROCEDURE, SUDDEN AND SIGNIFICANT BLEEDING OCCURRED AS A RESULT OF WHICH, THE PATIENT WAS TRANSFERRED TO INTENSIVE CARE UNIT FOR OBSERVATION AND TRANSFUSION. THE INTENDED PROCEDURE WAS COMPLETED WITH AN INTERVENTION PROCEDURE AND THE PATIENT IS REPORTED TO BE RECOVERING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1070407 ELECTROSURGICAL GENERATOR "ESG-300" HF-GENERATORS GEI OLYMPUS WINTER & IBE GMBH WA90003W

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R UNSPECIFIED DIATHERMY SNARE| UNSPECIFIED DIATHERMY SNARE