BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIDEO TELESCOPE "ENDOEYE HD II", 10 MM, 30°, AUTOCLAVABLE

    MDR report key: 24674862 · Received March 24, 2026

    Report

    Report Number
    9610773-2026-02171
    Event Type
    Malfunction
    Date Received
    March 24, 2026
    Date of Event
    November 6, 2025
    Report Date
    March 24, 2026
    Manufacturer
    OLYMPUS WINTER & IBE GMBH
    Product Code
    HET
    UDI-DI
    04042761074971
    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. A ROOT CAUSE COULD NOT BE IDENTIFIED. BASED ON THE RESULTS OF THE INVESTIGATION, THE MOST PROBABLE CAUSE OF THE FOREIGN MATERIAL IN THE LUER-LOCK (LLK) PLUG OF THE VIDEO-CABLE SECTION IS CAUSE NOT ESTABLISHED AND THE MOST PROBABLE CAUSE OF THE DAMAGED FIBER BONDING IN THE OUTER TUBE AREA (DISTAL END) 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.

    Description of Event or Problem · 0

    IT WAS OBSERVED DURING THE DEVICE EVALUATION THAT THE GYNECOLOGIC LAPAROSCOPE EXHIBITED DAMAGED FIBER BONDING IN THE OUTER TUBE AREA (DISTAL END) AND FOREIGN MATERIAL IN THE LUER-LOCK (LLK) PLUG OF THE VIDEO-CABLE SECTION. NO PATIENTS WERE INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    737903 VIDEO TELESCOPE "ENDOEYE HD II", 10 MM, 30°, AUTOCLAVABLE LAPAROSCOPE, GYNECOLOGIC HET OLYMPUS WINTER & IBE GMBH WA50042A 04042761074971

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown