BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HF UNIT "ESG-400"

    MDR report key: 13770086 · Received March 15, 2022

    Report

    Report Number
    9610773-2022-00097
    Event Type
    Injury
    Date Received
    March 15, 2022
    Date of Event
    January 16, 2022
    Report Date
    March 15, 2022
    Manufacturer
    OLYMPUS WINTER & IBE GMBH
    Product Code
    GEI
    Adverse Event
    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. THERE WERE NO REPORTS OF ANY MALFUNCTION OF THE HF-GENERATOR DURING THE PROCEDURE AND BASED ON THE AVAILABLE INFORMATION THE GENERATOR IS ASSUMED TO MEET ITS SPECIFICATION. THE EXACT CAUSE OF THE REPORTED PHENOMENON AND THE PATIENT¿S OUTCOME COULD NOT BE DETERMINED AND IS BEING JUDGED AS UNKNOWN. HOWEVER, BASED ON THE INFORMATION AVAILABLE, THE REPORTED BURN INJURY WAS MOST LIKELY CAUSED BY A FAULT CURRENT SUPPLIED BY THE ESG-400 HF-GENERATOR RESULTING FROM INCORRECT/UNSUITABLE POSITIONING OF THE PATIENT IN CONJUNCTION WITH POSSIBLY INCORRECT USE OF THE INVOLVED INSTRUMENTS. THEREFORE, THE PATIENT INJURY CAN IN ALL LIKELIHOOD BE ATTRIBUTED TO A USER ERROR. 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. 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): K203682; PRODUCT CODE: GEI.

    Description of Event or Problem · 0

    OLYMPUS WAS INFORMED THAT AFTER A SUCCESSFULLY COMPLETED THERAPEUTIC LAPAROSCOPIC EXTRAPFASCIAL HYSTERECTOMY PROCEDURE IT WAS FOUND THAT THE ELASTIC SOCK ON THE PATIENT'S LEFT KNEE WAS BURNED AND THE SKIN UNDERNEATH WAS SCALDED. THERE WAS NO REPORT ABOUT A MALFUNCTION OF ANY OF THE OLYMPUS DEVICES USED DURING THE PROCEDURE AND THERE WAS NO INFORMATION THAT ANY ADDITIONAL MEDICAL TREATMENT WAS ADMINISTERED TO TREAT THE BURN INJURY. THE PATIENT HAS BEEN DISCHARGED FROM THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    601942 HF UNIT "ESG-400" HF-GENERATORS GEI OLYMPUS WINTER & IBE GMBH WB91051C