BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TELESCOPE "OES ELITE", 4 MM, 12°, HD, AUTOCLAVABLE

    MDR report key: 19856593 · Received July 29, 2024

    Report

    Report Number
    9610773-2024-01836
    Event Type
    Malfunction
    Date Received
    July 29, 2024
    Report Date
    August 9, 2024
    Manufacturer
    OLYMPUS WINTER & IBE GMBH
    Product Code
    FGC
    PMA / PMN Number
    K151191
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TC
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE EVALUATION IS ONGOING. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE THE RESULTS OF THE LEGAL MANUFACTURER'S FINAL INVESTIGATION. IT HAS BEEN OVER ONE (1) YEAR SINCE THE SUBJECT DEVICE WAS MANUFACTURED. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO DEVIATIONS OR NON-CONFORMITIES THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. BASED ON THE RESULTS OF THE INVESTIGATION, OLYMPUS CONFIRMED THE DISTAL LENS OF THE SCOPE IS DAMAGED. IN ADDITION TO THAT, THE SCOPE REPRODUCES A FOGGY IMAGE DUE TO THE BROKEN LENS. THE REPORTED ISSUES ARE MOST LIKELY CAUSED BY EXCESSIVE FORCE DUE TO AN IMPACT, DROP OR FALL. OLYMPUS WILL CONTINUE TO MONITOR THE FIELD PERFORMANCE FOR THIS DEVICE.

    Description of Event or Problem · 0

    IT WAS OBSERVED THAT DURING THE DEVICE INSPECTION, THE TELESCOPE EXHIBITED AN IMAGE THAT WAS FOGGY DUE TO A BROKEN DISTAL END LENS. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    244863 TELESCOPE "OES ELITE", 4 MM, 12°, HD, AUTOCLAVABLE TELESCOPE FGC OLYMPUS WINTER & IBE GMBH WA2T412A 820001

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown