BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OP TELESCOPE, 7°, 11 FR. X 220 MM, 7.5 FR. CHANNEL, ANGLED OCULAR

    MDR report key: 20157368 · Received September 6, 2024

    Report

    Report Number
    9610773-2024-02144
    Event Type
    Malfunction
    Date Received
    September 6, 2024
    Report Date
    October 18, 2024
    Manufacturer
    OLYMPUS WINTER & IBE GMBH
    Product Code
    FGA
    UDI-DI
    04042761023214
    PMA / PMN Number
    K853486
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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 REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE APPROVED FINAL INVESTIGATION. BASED ON THE INFORMATION PROVIDED FOR THE INVESTIGATION, THE PROBABLE CAUSE OF THE REPORTED EVENT WAS MOST LIKELY ATTRIBUTABLE TO IMPROPER HANDLING AND APPLICATION OF EXCESSIVE FORCE, IMPACT TO THE DEVICE LIKE FALL, SHOCK OR SIMILAR STRESS. 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 OBJECTIVE LENS OF THE TELESCOPE WAS BROKEN. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2041611 OP TELESCOPE, 7°, 11 FR. X 220 MM, 7.5 FR. CHANNEL, ANGLED OCULAR WA37025A FGA OLYMPUS WINTER & IBE GMBH A37025A 04042761023214

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown