BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HF UNIT "ESG-400"

    MDR report key: 6666213 · Received June 26, 2017

    Report

    Report Number
    9610773-2017-10003
    Event Type
    Injury
    Date Received
    June 26, 2017
    Date of Event
    June 11, 2017
    Report Date
    June 26, 2017
    Manufacturer
    OLYMPUS WINTER & IBE GMBH
    Product Code
    GEI
    PMA / PMN Number
    K141225
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUSPECT MEDICAL DEVICE HAS NOT YET BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION/INVESTIGATION. THEREFORE, THE EXACT CAUSE OF THE PATIENT'S INJURY 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 #: WB91051W; BRAND NAME: HF UNIT "ESG-400"; COMMON DEVICE NAME: HF- GENERATORS; 510(K): K141225; PRODUCT CODE: GEI.

    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. ((B)(4)), (B)(4)(RETURNED TO (B)(4) ON 2017-07-05). 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 INJURY 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 DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE, THE HIGH-FREQUENCY OUTPUT OF THE ESG-400 ELECTROSURGICAL GENERATOR COULD NOT BE ACTIVATED. THE ESG-400 ELECTROSURGICAL GENERATOR WAS REPLACED BY ANOTHER SIMILAR DEVICE AND THE INTENDED PROCEDURE WAS SUCCESSFULLY COMPLETED. HOWEVER, IT WAS NOTICED AFTER THE PROCEDURE THAT THE PATIENT HAD SUSTAINED BURNS WHOSE LOCATION AND SEVERITY IS UNKNOWN. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    449543 HF UNIT "ESG-400" HF- GENERATORS GEI OLYMPUS WINTER & IBE GMBH WB91051C

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention UNSPECIFIED HF CABLE| UNSPECIFIED NEUTRAL ELECTRODE