BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIDEO TELESCOPE "ENDOEYE HD II", 5.4 MM, 0°, AUTOCLAVABLE

    MDR report key: 23425354 · Received October 30, 2025

    Report

    Report Number
    9610773-2025-06735
    Event Type
    Malfunction
    Date Received
    October 30, 2025
    Report Date
    December 10, 2025
    Manufacturer
    OLYMPUS WINTER & IBE GMBH
    Product Code
    HET
    UDI-DI
    04042761075008
    PMA / PMN Number
    K190744
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE THE RESULTS OF THE FINAL INVESTIGATION. THE DEVICE WAS RETURNED TO OLYMPUS FOR INSPECTION AND THE REPORTED FAILURE WAS NOT CONFIRMED. IN ADDITION, THE FOLLOWING REPORTABLE MALFUNCTION WAS IDENTIFIED DURING THE DEVICE EVALUATION: OBJECTIVE FRAME HAS MOISTURE, THE UNIT HAS FIBER BREAKAGE, THE OBJECTIVE LENS IS DIRT'S, THE OUTER TUBE HAS SCRATCHES AND IS BENT, LIGHT GUIDE COVER GLASS HAS CHIPS, THE VIDEO CONNECTOR IS CRACKED, THE LIGHT TRANSMISSION FAILED. A DEFINITIVE ROOT CAUSE COULD NOT BE IDENTIFIED. BASED ON THE RESULTS OF THE INVESTIGATION, AND SINCE THE DEVICE MALFUNCTION WAS NOT CONFIRMED DURING EVALUATION, THE DEFINITIVE ROOT CAUSE OF THE REPORTED ISSUE COULD NOT BE DETERMINED, ADDITIONALLY THE MOST PROBABLE CAUSE OF THE MALFUNCTION IS TRACED TO COMPONENT FAILURE 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

    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

    NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SUBJECT DEVICE DISPLAYED AN ERROR MESSAGE DURING THE CARTRIDGE CLEANING PROCESS. THERE WERE NO REPORTS OF PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2250942 VIDEO TELESCOPE "ENDOEYE HD II", 5.4 MM, 0°, AUTOCLAVABLE RIGID VIDEO LAPAROSCOPE HET OLYMPUS WINTER & IBE GMBH WA50050A 04042761075008

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown