BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 16050464 · Received December 27, 2022

    Report

    Report Number
    9610773-2022-00735
    Event Type
    Malfunction
    Date Received
    December 27, 2022
    Date of Event
    September 23, 2022
    Report Date
    December 27, 2022
    Manufacturer
    OLYMPUS WINTER & IBE GMBH
    Product Code
    HET
    UDI-DI
    04042761074971
    PMA / PMN Number
    K111788
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MC
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE SUSPECT MEDICAL DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR INVESTIGATION/EVALUATION BUT TO THE OLYMPUS HONG KONG (OHC) (RETURNED TO OHC ON (B)(6) 2022). THE EVALUATION AT OHC CONFIRMED THE OCCURRENCE OF GREEN IMAGE AND TRACED IT BACK TO A DEFECTIVE R-UNIT AND CABLE ASSEMBLY. THUS, THE REPORTED INCIDENT WAS ATTRIBUTED TO COMPONENT FAILURE. THE REPORTED OCCURRENCE OF A PURPLE IMAGE COULD NOT BE REPRODUCED. 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 RESULT.

    Description of Event or Problem · 0

    OLYMPUS WAS INFORMED THAT DURING PREPARATION FOR USE FOR AN UNSPECIFIED PROCEDURE, THE VIDEO TELESCOPE DISPLAYED A PURPLE IMAGE. NO FURTHER INFORMATION WAS PROVIDED BUT THERE WAS NO REPORT ABOUT AN ADVERSE EVENT OR PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    442034 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