BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIDEO-OPTIK "ENDOEYE 3D", 30°

    MDR report key: 19763676 · Received July 17, 2024

    Report

    Report Number
    9610773-2024-31756
    Event Type
    Malfunction
    Date Received
    July 17, 2024
    Date of Event
    July 10, 2024
    Report Date
    July 17, 2024
    Manufacturer
    OLYMPUS WINTER & IBE GMBH
    Product Code
    GCM
    UDI-DI
    04042761083492
    PMA / PMN Number
    K193026
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE RESULTS OF THE INVESTIGATION, IT IS LIKELY THAT THE FOLLOWING LED TO THE MALFUNCTION: THE MOST PROBABLE CAUSE OF THE COMPLAINT IS A CAUSE TRACED TO COMPONENT FAILURE. A DEVICE HISTORY RECORD REVIEW REVEALED NO ISSUES THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. 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 SCOPE EXHIBITED MINOR DENTS ON THE DISTAL EDGE. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    351328 VIDEO-OPTIK "ENDOEYE 3D", 30° Endoscope, rigid GCM OLYMPUS WINTER & IBE GMBH WA50082A 04042761083492

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown