BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HF UNIT "ESG-400"

    MDR report key: 10487178 · Received September 3, 2020

    Report

    Report Number
    9610773-2020-00202
    Event Type
    Malfunction
    Date Received
    September 3, 2020
    Date of Event
    August 28, 2020
    Report Date
    September 22, 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 THE MANUFACTURER FOR EVALUATION/INVESTIGATION. THEREFORE, THE EVALUATION WAS PERFORMED EXCLUSIVELY ON THE BASIS OF THE INFORMATION PROVIDED BY THE CUSTOMER. THE REPORTED ERROR MESSAGE E433 IS TRIGGERED BY THE GENERATOR¿S SAFETY SYSTEM AND CAN HAVE DIFFERENT TECHNICAL CAUSES. HOWEVER, THE CAUSE FOR THE OCCURRENCE OF THE ERROR MESSAGE COULD NOT BE DETERMINED IN THIS CASE. BASED ON THE INFORMATION AVAILABLE, THE EXACT CAUSE OF THE REPORTED PHENOMENON AND THE USER¿S EXPERIENCE 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 AND 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 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 CHOLECYSTECTOMY PROCEDURE, ERROR CODE "E433 - INTERNAL HARDWARE ERROR" WAS DISPLAYED AND THE HIGH-FREQUENCY OUTPUT OF THE ESG-400 ELECTROSURGICAL GENERATOR COULD NOT BE ACTIVATED. HOWEVER, THE INTENDED PROCEDURE WAS SUCCESSFULLY COMPLETED USING THE SAME DEVICE AND THERE WAS NO REPORT ABOUT AN ADVERSE EVENT OR PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    952641 HF UNIT "ESG-400" HF-GENERATORS GEI OLYMPUS WINTER & IBE GMBH WB91051C

    Patients

    Seq Age Sex Outcome Treatment
    1 OLYMPUS VISERA ELITE LIGHT SOURCE CLV-S190.| OLYMPUS VISERA ELITE VIDEO SYSTEM CENTER OTV-S190.