BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIDEO TELESCOPE "ENDOEYE HD II", 10 MM, 30°, AUTOCLAVABLE

    MDR report key: 16093196 · Received January 4, 2023

    Report

    Report Number
    9610773-2023-00067
    Event Type
    Malfunction
    Date Received
    January 4, 2023
    Date of Event
    December 1, 2021
    Report Date
    January 4, 2023
    Manufacturer
    OLYMPUS WINTER & IBE GMBH
    Product Code
    HET
    UDI-DI
    04042761074971
    PMA / PMN Number
    K111788
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE SUSPECT MEDICAL DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION/INVESTIGATION BUT TO OLYMPUS HONGKONG & CHINA LTD. (OHC), (RECEIVED AT OHC ON 2022-12-07). THE INSPECTION AT OHC DETECTED VARYING COLOURED IMAGES (PURPLE/GREEN) AND TRACED THE FAILURE BACK TO A DEFECTIVE R-UNIT. THEREFORE, THIS EVENT/INCIDENT WAS ATTRIBUTED TO COMPONENT FAILURE. THE REPORTED LEAKINESS COULD NOT BE CONFIRMED. THE AREA UNDER THE HANDLE (AS WELL AS UNDER THE INNER BODY) IS NOT A SEALED VOLUME. CONSEQUENTLY, MOISTURE IN THE REPORTED AREAS DO NOT INDICATE A DEFICIENCY OF THE DEVICE. A MATERIAL OR QUALITY PROBLEM CAN BE EXCLUDED SINCE A MANUFACTURING AND QUALITY CONTROL REVIEW WAS PERFORMED FOR THE AFFECTED SERIAL NUMBER OF THE VIDEO TELESCOPE 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.

    Description of Event or Problem · 0

    THE LOANER VIDEO TELESCOPE REPORTEDLY DISPLAYED A PURPLE IMAGE AND SHOWED LEAKINESS AT THE ASSEMBLY OF THE OUTER TUBE AND R-UNIT. NO PATIENT/PROCEDURE WAS INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1199341 VIDEO TELESCOPE "ENDOEYE HD II", 10 MM, 30°, AUTOCLAVABLE RIGID VIDEO SCOPE HET OLYMPUS WINTER & IBE GMBH WA50042A 04042761074971

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown