BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 23544767 · Received November 13, 2025

    Report

    Report Number
    9610773-2025-07042
    Event Type
    Malfunction
    Date Received
    November 13, 2025
    Date of Event
    October 16, 2025
    Report Date
    November 13, 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
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED TO OLYMPUS FOR INSPECTION. A ROOT CAUSE COULD NOT BE IDENTIFIED. BASED ON THE RESULTS OF THE INVESTIGATION, IT IS LIKELY THE FOLLOWING LED TO THE MALFUNCTION: THE MOST PROBABLE CAUSE OF THE COMPLAINT IS CAUSE 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.

    Description of Event or Problem · 0

    IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE RIGID VIDEO LAPAROSCOPE EXHIBITED DISTAL FIBERS BREAKAGE, OUTER TUBE HAD DENTS AND A BENT, LIGHT GUIDE CABLE HAD A CUT, LEAKAGE AT PROTECTOR RING ON THE LIGHT GUIDE CONNECTOR, PRONG, COVER GLASS AND THE LIGHT TRANSMISSION FAILED. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1883116 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