BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIDEO TELESCOPE "ENDOEYE", 10 MM, 30°, PAL, HD COMPATIBLE, AUTOCLAVABLE

    MDR report key: 24694350 · Received March 25, 2026

    Report

    Report Number
    9610773-2026-02270
    Event Type
    Malfunction
    Date Received
    March 25, 2026
    Date of Event
    January 21, 2026
    Report Date
    March 25, 2026
    Manufacturer
    OLYMPUS WINTER & IBE GMBH
    Product Code
    NWB
    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 ADDITIONAL MALFUNCTION DAMAGED FIBRE BONDING IN THE OUTER TUBE AREA (DISTAL END) WAS TRACED TO COMPONENT FAILURE, AND PROBABLE CAUSE OF FOREIGN MATERIAL IN LIGHT GUIDE CABLE (LLK) PLUG OF THE VIDEO CABLE SECTION COULD NOT BE 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 THAT DURING THE DEVICE EVALUATION, THE RIGID VIDEO LAPAROSCOPE EXHIBITED DAMAGED FIBRE BONDING IN THE OUTER TUBE AREA (DISTAL END), AND FOREIGN MATERIAL IN LIGHT GUIDE CABLE (LLK) PLUG OF THE VIDEO CABLE SECTION. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    745345 VIDEO TELESCOPE "ENDOEYE", 10 MM, 30°, PAL, HD COMPATIBLE, AUTOCLAVABLE RIGID VIDEO LAPAROSCOPE NWB OLYMPUS WINTER & IBE GMBH WA50012A

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown