BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HF UNIT "ESG-400"

    MDR report key: 10243449 · Received July 8, 2020

    Report

    Report Number
    9610773-2020-00152
    Event Type
    Malfunction
    Date Received
    July 8, 2020
    Date of Event
    July 1, 2020
    Report Date
    July 31, 2020
    Manufacturer
    OLYMPUS WINTER & IBE GMBH
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE SUSPECT MEDICAL DEVICE WAS NOT RETURNED TO OLYMPUS FOR EVALUATION/INVESTIGATION. THEREFORE, THE EXACT CAUSE OF THE USER'S EXPERIENCE AND THE REPORTED PHENOMENON 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 FROM OLYMPUS SIDE WITH NO FURTHER ACTIONS. HOWEVER, THE REPORTED EVENT/INCIDENT WILL BE RECORDED FOR TRENDING AND SURVEILLANCE PURPOSES.

    Additional Manufacturer Narrative · 1

    THE SUSPECT MEDICAL DEVICE HAS NOT YET BEEN RETURNED TO OLYMPUS FOR EVALUATION/INVESTIGATION. THEREFORE, THE EXACT CAUSE OF THE USER'S EXPERIENCE 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.

    Description of Event or Problem · 1

    OLYMPUS WAS INFORMED THAT DURING A THERAPEUTIC TRANSURETHRAL RESECTION OF THE PROSTATE (TURP) PROCEDURE, THE HF-GENERATOR 'ESG-400' ISSUED ERROR MESSAGE E433. THE INTENDED PROCEDURE WAS COMPLETED USING A SIMILAR DEVICE AND THERE WAS NO REPORT ABOUT AN ADVERSE EVENT OR PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    708510 HF UNIT "ESG-400" HF-GENERATORS GEI OLYMPUS WINTER & IBE GMBH WB91051C

    Patients

    Seq Age Sex Outcome Treatment
    1