BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIDEO TELESCOPE "ENDOEYE HD II", 5.4 MM, 30°, AUTOCLAVABLE

    MDR report key: 21496759 · Received February 28, 2025

    Report

    Report Number
    9610773-2025-01710
    Event Type
    Malfunction
    Date Received
    February 28, 2025
    Date of Event
    February 19, 2025
    Report Date
    April 3, 2025
    Manufacturer
    OLYMPUS WINTER & IBE GMBH
    Product Code
    HET
    PMA / PMN Number
    K190744
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE THE RESULTS OF THE LEGAL MANUFACTURER'S FINAL INVESTIGATION. UPDATED FIELDS: D4, D8, D9, H2, H3, H6, H11. CORRECTED FIELDS: B5. THE DEVICE WAS RETURNED TO OLYMPUS FOR INSPECTION AND THE REPORTED FAILURE WAS CONFIRMED. IN ADDITION, THE FOLLOWING REPORTABLE MALFUNCTIONS WERE IDENTIFIED DURING THE DEVICE EVALUATION: FLICKERING IMAGE, DARK IMAGE, BENT LIGHT GUIDE BUNDLE AT THE REAR END AND COMPONENT FAILURE OF THE ELECTRONICAL COMPONENT, LIGHT GUIDE BUNDLE AND TRANSMISSION COMPONENT. A ROOT CAUSE COULD NOT BE IDENTIFIED. BASED ON THE RESULTS OF THE INVESTIGATION, IT IS LIKELY THAT BLACK IMAGE WAS CAUSED DUE TO COMPONENT FAILURE OF THE ELECTRONICAL COMPONENT. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Additional Manufacturer Narrative · 0

    E1-FACILITY NAME: (B)(6). THE INVESTIGATION IS ONGOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETED OR IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THE ISSUE OCCURRED DURING REPROCESSING.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SUBJECT DEVICE HAD BLACK IMAGE. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    521708 VIDEO TELESCOPE "ENDOEYE HD II", 5.4 MM, 30°, AUTOCLAVABLE RIGID VIDEO LAPAROSCOPE HET OLYMPUS WINTER & IBE GMBH WA50052A

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown