BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ELECTROSURGICAL GENERATOR "ESG-300"

    MDR report key: 15359611 · Received September 6, 2022

    Report

    Report Number
    9610773-2022-00369
    Event Type
    Injury
    Date Received
    September 6, 2022
    Date of Event
    August 11, 2022
    Report Date
    September 6, 2022
    Manufacturer
    OLYMPUS WINTER & IBE GMBH
    Product Code
    GEI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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 HF-GENERATOR OR ANY OF THE OTHER MEDICAL DEVICES USED DURING THE PROCEDURE. 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 · 0

    OLYMPUS WAS INFORMED THAT THREE DAYS AFTER A THERAPEUTIC RECTAL ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD) PROCEDURE HAD BEEN PERFORMED, THE PATIENT CONDITION DETERIOATED AND WHEN A LARGE INTESTINE EXAMINATION WAS PERFORMED, IT WAS DISCOVERED THAT BLOOD HAD ACCUMULATED IN THE INTESTINAL MEMBRANE OF THE LARGE INTESTINE (LOCATION UNKNOWN). IT IS UNKNOWN WHETHER THIS WAS THE CAUSE OF THE DETERIORATION OF THE PATIENT'S CONDITION. NO FURTHER INFORMATION ABOUT ADDITIONAL TREATMENT WAS PROVIDED BUT THE PATIENT'S HOSPITALIZATION PERIOD WAS EXTENDED. THERE WAS NO REPORT OF A MALFUNCTION OF ANY OF THE MEDICAL DEVICES USED DURING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    134950 ELECTROSURGICAL GENERATOR "ESG-300" HF-GENERATORS GEI OLYMPUS WINTER & IBE GMBH WA90003J

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Hospitalization OLYMPUS EVIS LUCERA ELITE VIDEOGASTROSC. GIF-H290T| OLYMPUS SU ELECTROSURG. DUALKNIFE J KD-655Q| OLYMPUS SU HAEMOSTATIC FORCEPS FD-411QR