BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 25267025 · Received May 24, 2026

    Report

    Report Number
    9610773-2026-04031
    Event Type
    Malfunction
    Date Received
    May 24, 2026
    Date of Event
    April 21, 2026
    Report Date
    May 24, 2026
    Manufacturer
    OLYMPUS WINTER & IBE GMBH
    Product Code
    HET
    UDI-DI
    04042761075015
    PMA / PMN Number
    K190744
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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: BENT LIGHT GUIDE WAS CAUSED DUE TO A COMPONENT FAILURE OF THE LIGHT GUIDE ADAPTER. AND CHIPPED LIGHT GUIDE BUNDLE WAS CAUSED DUE TO A COMPONENT FAILURE OF THE LIGHT GUIDE BUNDLE. 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

    THE CUSTOMER RETURNED THE RIGID VIDEO LAPAROSCOPE, WHICH IS AN OLYMPUS ASSET WITH NO REPORTED COMPLAINT. DURING THE EVALUATION OF THE DEVICE, BENT LIGHT GUIDE AND CHIPPED LIGHT GUIDE BUNDLE WERE OBSERVED. THE REGIONAL SERVICE CENTER INDICATED THAT THE MOST LIKELY CAUSE OF THE BENT LIGHT GUIDE WAS DUE TO COMPONENT FAILURE OF LIGHT GUIDE ADAPTER AND CHIPPED LIGHT GUIDE BUNDLE WAS DUE TO COMPONENT FAILURE OF THE LIGHT GUIDE BUNDLE. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    114628 VIDEO TELESCOPE "ENDOEYE HD II", 5.4 MM, 30°, AUTOCLAVABLE RIGID VIDEO LAPAROSCOPE HET OLYMPUS WINTER & IBE GMBH WA50052A 04042761075015

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown