BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 25116661 · Received May 7, 2026

    Report

    Report Number
    9610773-2026-03614
    Event Type
    Malfunction
    Date Received
    May 7, 2026
    Report Date
    May 7, 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
    GM
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED TO OLYMPUS FOR INSPECTION. BASED ON THE RESULTS OF THE INVESTIGATION, A PROBABLE ROOT CAUSE COULD NOT BE IDENTIFIED. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. BASED ON THE RESULTS OF THE INVESTIGATION, THE MOST PROBABLE CAUSE OF THE DEFORMED OUTER TUBE WAS TRACED TO COMPONENT FAILURE, HOWEVER THE CAUSE OF THE FOREIGN MATERIAL FOUND IN THE LLK PLUG (LASER LIGHT CABLE) OF THE VIDEO CABLE SECTION COULD NOT BE ESTABLISHED. DATE OF EVENT IS UNKNOWN. 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 HAD FOREIGN MATERIAL IN THE LLK (LASER LIGHT CABLE) PLUG OF THE VIDEO CONNECTOR AND EXHIBITED DEFORMED OUTER TUBE. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    118122 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