BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 25221581 · Received May 19, 2026

    Report

    Report Number
    9610773-2026-03861
    Event Type
    Malfunction
    Date Received
    May 19, 2026
    Date of Event
    May 1, 2026
    Report Date
    May 19, 2026
    Manufacturer
    OLYMPUS WINTER & IBE GMBH
    Product Code
    HET
    UDI-DI
    04042761075008
    PMA / PMN Number
    K111788
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    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

    IT WAS REPORTED THAT THE RIGID VIDEO LAPAROSCOPE HAD BROKEN ROD LENSES, BENT INSERTION TUBE AND NO CLEAR IMAGE. THE ISSUE WAS FOUND DURING REPROCESSING. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    282538 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