BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CMOS VIDEO CYSTO-URETHROSCOPE C-VIEW REV DEF

    MDR report key: 15018499 · Received July 14, 2022

    Report

    Report Number
    1221826-2022-00106
    Event Type
    Malfunction
    Date Received
    July 14, 2022
    Date of Event
    June 17, 2022
    Report Date
    July 15, 2022
    Manufacturer
    KARL STORZ ENDOVISION, INC.
    Product Code
    FAJ
    PMA / PMN Number
    K202957
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PER KSE EVALUATION OVERBEND ON PROXIMAL SHAFT. DENTS ON DISTAL TIP.

    Description of Event or Problem · 0

    IMAGE INTERRUPTION DUE TO ESU FAILURE. THE FACILITY PROVIDED NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2349148 CMOS VIDEO CYSTO-URETHROSCOPE C-VIEW REV DEF FLEXIBLE VIDEO CYSTO SCOPE FAJ KARL STORZ ENDOVISION, INC. R11272VUEK

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other