BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CMOS VIDEO CYSTO-URETHROSCOPE C-VIEW REV DEF

    MDR report key: 15093886 · Received July 25, 2022

    Report

    Report Number
    1221826-2022-00128
    Event Type
    Malfunction
    Date Received
    July 25, 2022
    Date of Event
    June 27, 2022
    Report Date
    November 10, 2022
    Manufacturer
    KARL STORZ ENDOVISION, INC.
    Product Code
    FAJ
    PMA / PMN Number
    K202957
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PER KSE/MFR. EVALUATION IS PENDING.

    Additional Manufacturer Narrative · 0

    IMAGE INTERRUPTION DUE TO ESU (ELECTROSURGICAL UNIT) FAILURE. EXTERNAL CUT ON SHAFT BEHIND PROXIMAL THREAD WRAP, LEAKS. OVER BEND ON PROXIMAL SHAFT 65MM FROM SHAFT ADAPTOR. LIGHT GUIDE PULLED BACK FROM DISTAL HEAD CAUSING LOW LIGHT OUTPUT, 30MW. OVER TEMPERATURE DOT TRIGGERED AT 180°F. RISK MANAGEMENT FILE HAS BEEN REVIEWED AND THIS HAZARD IS COVERED. THIS FAILURE MODE WAS CONFIRMED AND HAS BEEN DETERMINED TO BE DUE TO THE DURABILITY OF THE POWER CABLE. IAF 2022-07-25-01 HAS BEEN FILED FOR CAPA CONSIDERATION. CAPA 2022-0111 HAS BEEN ENTERED.

    Description of Event or Problem · 0

    IMAGE INTERRUPTION, THE MONITOR KEPT SHORTING OUT AND RESTARTING WHEN USING CAUTERY. THE PROCEDURE WAS COMPLETED. THE FACILITY PROVIDED NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1411471 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