BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ELECTROSURGICAL GENERATOR "ESG-300"

    MDR report key: 12696026 · Received October 26, 2021

    Report

    Report Number
    9610773-2021-00302
    Event Type
    Injury
    Date Received
    October 26, 2021
    Report Date
    December 1, 2021
    Manufacturer
    OLYMPUS WINTER & IBE GMBH
    Product Code
    GEI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION - D10 - CONCOMITANT MEDICAL PRODUCTS AND THERAPY DATESDEVICE EVALUATION: THE SUSPECT MEDICAL DEVICE WAS NOT RETURNED TO OLYMPUS FOR EVALUATION/INVESTIGATION. THEREFORE, THE INVESTIGATION/EVALUATION WAS PERFORMED EXCLUSIVELY ON THE BASIS OF THE INFORMATION PROVIDED BY THE CUSTOMER. 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, SINCE THERE WERE NO REPORTS OF ANY MALFUNCTION OF THE ELECTROSURGICAL GENERATOR, IT IS ASSUMED THAT IT WAS WITHIN SPECIFICATION AT THE TIME IN QUESTION. FURTHERMORE, 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 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 · 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 #: WA90003W; 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 ONE DAY AFTER A THERAPEUTIC COLONIC POLYPECTOMY PROCEDURE AT AN UNKNOWN DATE, THE PATIENT DEVELOPED A FEVER AND PNEUMONIA AND WAS ADMITTED AS AN EMERGENCY AND TREATED WITH OXYGEN. THE PATIENT WAS DISCHARGED AFTER MORE THAN ONE MONTH AND HAS BEEN RECEIVING OUTPATIENT TREATMENT FOR INTERSTITIAL PNEUMONIA. IT IS UNLIKELY THAT THE POLYPECTOMY WAS THE CAUSE OF THE PNEUMONIA. HOWEVER, THE POSSIBILITY OF ASPIRATION PNEUMONIA CANNOT BE RULED OUT. FURTHERMORE, EIGHT DAYS AFTER THE POLYPECTOMY, THE PATIENT DEVELOPED ABDOMINAL PAIN AND UNDERWENT EMERGENCY SURGERY FOR THE TREATMENT OF A PERFORATION IN THE SIGMOID COLON. SINCE THIS IS DISTANT FROM THE DUODENUM, A CAUSAL RELATIONSHIP WITH THE POLYPECTOMY PROCEDURE CAN BE EXCLUDED. THE CAUSE OF THE PERFORATION MAY BE A STRESS ULCER CAUSED BY FASTING OR OTHER FACTORS ASSOCIATED WITH THE TREATMENT OF PNEUMONIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1594337 ELECTROSURGICAL GENERATOR "ESG-300" HF-GENERATORS GEI OLYMPUS WINTER & IBE GMBH WA90003J

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Hospitalization| R OLYMPUS SNAREMASTER PLUS (10MM OR 15MM)