BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 16909096 · Received May 11, 2023

    Report

    Report Number
    9610773-2023-01285
    Event Type
    Malfunction
    Date Received
    May 11, 2023
    Date of Event
    April 12, 2023
    Report Date
    May 11, 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
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE HISTORY RECORDS FOR THE AFFECTED SERIAL NUMBER WAS REVIEWED WITHOUT SHOWING ANY NON-CONFORMITIES OR DEVIATIONS REGARDING THE DESCRIBED ISSUE. THE DEVICE WAS MANUFACTURED ACCORDING TO VALID INSTRUCTIONS AND MET ALL SPECIFICATIONS. THE DEVICE WAS RETURNED FOR INVESTIGATION. THE RESULT OF THE INVESTIGATION IS NOT CONSISTENT WITH THE CUSTOMER¿S REPORTED PROBLEM. AFTER LONG-TERM TESTING, THE REPORTED DEFECT/MALFUNCTION COULD NOT BE CONFIRMED OR REPRODUCED. THE INSPECTION OF THE DEVICE NOTE THE LIGHT GUIDE FIBER COMPOSITE AT THE DISTAL END IS DAMAGED AND THERE IS A CUT IN THE GREY PROTECTIVE SLEEVE. SINCE THE CUSTOMER PROBLEM COULD NOT BE REPRODUCED, THE CAUSE OF THE REPORTED EVEN COULD NOT BE DETERMINED. OLYMPUS WILL CONTINUE TO MONITOR THE FIELD PERFORMANCE FOR THIS DEVICE. IN GENERAL, THE END-USER IS REQUIRED TO INSPECT THE DEVICE FOR DEFECTS, CHECK THE FUNCTION OF ALL DEVICES AND HAVE ALTERNATE EQUIPMENT PRIOR TO USE. ADDITIONAL 510(K): K190744.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT DURING A THERAPEUTIC PROCEDURE A GREEN IMAGE APPEARED WITH THE ENDOEYE HIGH DEFINITION II, AUTOCLAVABLE VIDEO TELESCOPE. THE PROCEDURE WAS ABLE TO BE COMPLETED SUCCESSFULLY WITHOUT DELAY. NO DEATH OR INJURY AND NO HARM TO THE PATIENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1734651 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