BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIDEO TELESCOPE "ENDOEYE 3D", 10 MM, 0°

    MDR report key: 24732509 · Received March 30, 2026

    Report

    Report Number
    9610773-2026-02499
    Event Type
    Malfunction
    Date Received
    March 30, 2026
    Date of Event
    November 7, 2025
    Report Date
    March 30, 2026
    Manufacturer
    OLYMPUS WINTER & IBE GMBH
    Product Code
    GCM
    UDI-DI
    04042761083485
    PMA / PMN Number
    K193026
    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 INVESTIGATION RESULTS, THE REPORTABLE EVENT FIBRE BONDING IN THE OUTER TUBE AREA (DISTAL END) IS DAMAGED WAS CAUSED BY A COMPONENT FAILURE. HOWEVER, LLK PLUG OF THE VIDEO CABLE SECTION CONTAINS FOREIGN MATERIAL ALSO OCCURRED, BUT A DEFINITIVE ROOT CAUSE FOR THIS COULD NOT BE IDENTIFIED. 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 FIBRE BONDING IN THE OUTER TUBE AREA (DISTAL END) IS DAMAGED AND LLK PLUG OF THE VIDEO CABLE SECTION CONTAINS FOREIGN MATERIAL. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    792373 VIDEO TELESCOPE "ENDOEYE 3D", 10 MM, 0° RIGID VIDEO LAPAROSCOPE GCM OLYMPUS WINTER & IBE GMBH WA50080A 04042761083485

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown