BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 20189336 · Received September 11, 2024

    Report

    Report Number
    9610773-2024-02184
    Event Type
    Malfunction
    Date Received
    September 11, 2024
    Date of Event
    September 4, 2024
    Report Date
    November 15, 2024
    Manufacturer
    OLYMPUS WINTER & IBE GMBH
    Product Code
    FGC
    UDI-DI
    04042761077507
    PMA / PMN Number
    K151191
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE LEGAL MANUFACTURER'S FINAL INVESTIGATION. THE DEVICE WAS RETURNED TO OLYMPUS FOR INSPECTION, AND THE CUSTOMER'S COMPLAINT WAS CONFIRMED. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO DEVIATIONS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. BASED ON THE RESULTS OF THE INVESTIGATION, THE LIKELY CAUSE OF THE REPORTED EVENT IS DUE TO IMPROPER HANDLING AND APPLICATION OF EXCESSIVE FORCE, IMPACT TO THE DEVICE LIKE FALL, SHOCK OR SIMILAR STRESS. HOWEVER, THE ROOT CAUSE OF THE REPORTED EVENT IS UNABLE TO BE DETERMINED. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    IT WAS REPORTED THE TELESCOPE HAD A LOOSE BLUE RING COMPONENT. THERE WERE NO REPORTS OF PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    567203 TELESCOPE "OES ELITE", 4 MM, 12°, HD, AUTOCLAVABLE WA2T412A FGC OLYMPUS WINTER & IBE GMBH WA2T412A 803508 04042761077507

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown