BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HF UNIT "ESG-400"

    MDR report key: 5549723 · Received April 6, 2016

    Report

    Report Number
    9610773-2016-00003
    Event Type
    Injury
    Date Received
    April 6, 2016
    Date of Event
    January 20, 2016
    Report Date
    January 27, 2016
    Manufacturer
    OLYMPUS WINTER & IBE GMBH
    Product Code
    GEI
    PMA / PMN Number
    K141225
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUSPECT MEDICAL DEVICE AND CONCOMITANT MEDICAL PRODUCTS WERE NOT RETURNED TO THE MANUFACTURER FOR EVALUATION/INVESTIGATION BUT TO OLYMPUS (B)(4) (RETURNED TO OCM ON 2016-01-21). HOWEVER, THE EXACT CAUSE OF THE PATIENT'S OUTCOME AND THE REPORTED PHENOMENON COULD NOT BE DETERMINED YET, SINCE THE EVALUATION/INVESTIGATION IS STILL ONGOING. AS SOON AS THE INVESTIGATION RESULTS AND FINAL EVALUATION ARE AVAILABLE, THIS REPORT WILL BE UPDATED. RESUBMISSION OF THE INITIAL REPORT AFTER THE SUBMISSION FROM 2016-01-27 HAS FAILED WITH ERROR_MESSAGE "(40) CHARACTERS ARE MAX." IN (B)(6).

    Additional Manufacturer Narrative · 1

    THE ESG-400 ELECTROSURGICAL GENERATOR WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION/INVESTIGATION BUT TO OLYMPUS ((B)(4)) SALES & SERVICE CO., LTD. (OCM), (B)(4) (RETURNED TO OCM ON (B)(6) 2016). WHEN THE SUSPECT MEDICAL DEVICE WAS INSPECTED AND TESTED, IT WAS FOUND TO BE IN GOOD WORKING ORDER AND IN ACCORDANCE WITH ITS SPECIFICATIONS. NO ABNORMALITY, DEFECT, FAILURE OR MALFUNCTION WAS FOUND DURING THE PERFORMANCE TESTS. THEREFORE, THE EXACT CAUSE OF THE PATIENT'S OUTCOME AND THE REPORTED PHENOMENON COULD NOT BE CONCLUSIVELY DETERMINED AND IS BEING JUDGED AS UNKNOWN. HOWEVER, IT CAN BE EXCLUDED THAT IT WAS CAUSED BY A MALFUNCTION OF THE ESG-400 ELECTROSURGICAL GENERATOR. THE CASE WILL BE CLOSED FROM OLYMPUS SIDE WITH NO FURTHER ACTIONS, BUT THE REPORTED PHENOMENON WILL BE RECORDED FOR TRENDING AND SURVEILLANCE PURPOSES.

    Description of Event or Problem · 1

    OLYMPUS WAS INFORMED THAT ONE DAY AFTER A THERAPEUTIC BIPOLAR TRANSURETHRAL RESECTION OF THE PROSTATE (TURP) PROCEDURE, THE PATIENT FELT PAIN AND IT WAS NOTICED THAT HE HAD SUSTAINED A THIRD-DEGREE BURN ON THEIR LEFT HIP. NO FURTHER INFORMATION WAS PROVIDED AND THE PATIENT'S CURRENT CONDITION AND OUTCOME IS ALSO UNKNOWN. HOWEVER, THE PROCEDURE WAS COMPLETED WITHOUT ANY COMPLICATIONS AND THERE WAS NO ALLEGED MALFUNCTION OF AN OLYMPUS MEDICAL DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    208899 HF UNIT "ESG-400" HF- GENERATORS GEI OLYMPUS WINTER & IBE GMBH WB91051C

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention| S