BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIDEO-OPTIK "ENDOEYE 3D", 30°

    MDR report key: 23842522 · Received December 18, 2025

    Report

    Report Number
    9610773-2025-08350
    Event Type
    Malfunction
    Date Received
    December 18, 2025
    Date of Event
    September 27, 2025
    Report Date
    December 18, 2025
    Manufacturer
    OLYMPUS WINTER & IBE GMBH
    Product Code
    GCM
    UDI-DI
    04042761083492
    PMA / PMN Number
    K193026
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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 WAS TRACED TO COMPONENT FAILURE. THE MOST PROBABLE CAUSE FOR THE FOREIGN MATERIAL IN THE LASER LIGHT CABLE (LLK) PLUG OF THE VIDEO CABLE SECTION WAS NOT ESTABLISHED. 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 RIGID VIDEO LAPAROSCOPE EXHIBITED DAMAGED FIBER BONDING IN THE OUTER TUBE AREA (DISTAL END) WAS DAMAGED; BROKEN MENISCUS OF THE CHARGE COUPLED DEVICE (R-UNIT) SECTION; AND THE FOREIGN MATERIAL IN LASER LIGHT CABLE (LLK) PLUG OF THE VIDEO CABLE SECTION. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2241796 VIDEO-OPTIK "ENDOEYE 3D", 30° RIGID VIDEO LAPAROSCOPE GCM OLYMPUS WINTER & IBE GMBH WA50082A 04042761083492

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown