BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OP-TELESCOPE, 30°, 4 MM CHANNEL

    MDR report key: 20296883 · Received September 24, 2024

    Report

    Report Number
    9610773-2024-02328
    Event Type
    Malfunction
    Date Received
    September 24, 2024
    Date of Event
    September 18, 2024
    Report Date
    May 9, 2025
    Manufacturer
    OLYMPUS WINTER & IBE GMBH
    Product Code
    FGA
    UDI-DI
    04042761051866
    PMA / PMN Number
    K853486
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ND, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE EVALUATION OF THE EVENT 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 LEGAL MANUFACTURER'S INVESTIGATION. THE CUSTOMER'S ALLEGATION WAS NOT CONFIRMED. THE DEVICE WAS NOT RETURNED FOR EVALUATION AND COULD NOT BE EVALUATED. BASED ON THE RESULTS OF THE INVESTIGATION, IT IS POSSIBLE THAT THE FOLLOWING LED TO THE MALFUNCTION: EFFECT OF A LARGE MECHANICAL FORCE DUE TO A SHOCK, FALL OR COLLISION WITH OTHER EQUIPMENT. HOWEVER, A DEFINITIVE ROOT CAUSE CANNOT BE IDENTIFIED. A DEVICE HISTORY REVIEW REVEALED NO ISSUES THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. OLYMPUS WILL CONTINUE TO MONITOR THE FIELD PERFORMANCE OF THIS DEVICE. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE OP-TELESCOPE HAD BROKEN OFF COMPONENTS. THERE WERE NO REPORTS OF PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1098522 OP-TELESCOPE, 30°, 4 MM CHANNEL WA33036A FGA OLYMPUS WINTER & IBE GMBH WA33036A 04042761051866

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown