BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIDEO FLEXIBLE CYSTOSCOPE

    MDR report key: 15261771 · Received August 19, 2022

    Report

    Report Number
    9610617-2022-00249
    Event Type
    Malfunction
    Date Received
    August 19, 2022
    Date of Event
    July 22, 2022
    Report Date
    June 27, 2023
    Manufacturer
    KARL STORZ SE & CO. KG
    Product Code
    FAJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE AFFECTED ARTICLE HAS BEEN REQUESTED FOR INVESTIGATION BY THE MANUFACTURER AND IS IN TRANSIT TO THE MANUFACTURING SITE IN GERMANY.

    Additional Manufacturer Narrative · 0

    IT WAS BROUGHT TO OUR ATTENTION THAT INFORMATION REGARDING THE RETURN OF THE PRODUCT TO THE MANUFACTURER WAS INCORRECT. THE PRODUCT WAS NOT RETURNED FOR EVELUATION. FURTHERMORE, THE MANUFACTUING NUMBER FOR THIS CASE IS INCORRECT AND SHOULD REFELCT THE KSE MANUFACTUIGN NUMBER 1221826 INSTEAD OF THE KST MANUFACTURING NUMBER 9610617.

    Additional Manufacturer Narrative · 0

    PER THE SALES REPRESENTATIVE, THE PRODUCT WAS NOT RETURNED; THEREFORE AN EVALUATION AND ROOT CAUSE ANALYSIS COULD NOT BE PREFORMED. THERE HAS BEEN NO DOCUMENTED INSTANCES OF THIS DEFECT OCCURRING ON THE 11272VH HD CYSTOSCOPE. DUE TO THE PRODUCT NOT BEING RETURNED, AN EVALUATION WAS NOT PREFORMED THEREFORE THE HAZARD COULD NOT BE CONFIRMED BY KSE. HOWEVER, AN IAF HAS BEEN INITIATED TO DETERMINE IF A CAPA OR ADDITIONAL ACTIONS ARE NEEDED. THE ITEM IN QUESTION WAS RETURNED TO THE MANUFACTURER. THE EVALUATION IS NOT COMPLETE BUT THE NEW ESTAMIATED COMPLETION DATE FOR THIS IS APROXIMENTLY EARLY MARCH 2023. INTERNAL KARL STORZ REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 0

    THIS REPORT IS TO CORRECT THE AWARE DATE OF LAST SUPPLEMENTAL SUBMISSION 22-249_SUP3. THE CORRECT AWARE DATE WAS JANUARY 1, 2023 AND NOT JANUARY 12, 2023. THE EVENT IS FILED UNDER INTERNAL KARL STORZ COMPLAINT ID: (B)(4).

    Additional Manufacturer Narrative · 0

    THE REPORTED IMAGE LOSS COULD NOT BE DUPLICATED BY KSE'S INTERNAL TESTING. ADDITIONAL TESTING OF OUTGOING PRODUCTS ALSO YIELD NO OCCURRENCES OF THIS FAILURE MODE. RISK MANAGEMENT FILE HAS BEEN REVIEWED AND THIS HAZARD IS COVERED. CUSTOMER DID NOT REPORT A PATIENT INJURY, THEREFORE NO FURTHER ACTION WILL BE TAKEN. THE EVENT IS FILED UNDER INTERNAL KARL STORZ COMPLAINT ID: (B)(4).

    Additional Manufacturer Narrative · 0

    PER TRENDING, KSE HAS NOT SEEN PREVIOUS INSTANCES OF THIS DEFECT OCCURRING ON THE 11272VH HD CYSTOSCOPE BUT HAS SEEN THIS DEFECT ON A SCOPE OF A DIFFERENT DESIGN. AS A RESULT OF THE DEFECT BEING SEEN ON SCOPES OF A DIFFERENT DESIGN AND THE ABSENCE OF THE PRODUCT BEING RETURNED, IT WAS DETERMINED KSE WOULD PERFORM TESTING ON THIS MODEL SCOPE, OVER A SET PERIOD OF TIME, IN AN EFFORT TO DETERMINE IF THE DEFECT WOULD BE SEEN ON PRODUCT OF THE SAME DESIGN. NO ISSUES WERE NOTED. THE MANUFACTURING NUMBER FOR THIS CASE IS INCORRECT AND SHOULD REFLECT THE KSE MANUFACTUIGN NUMBER 1221826. INSTEAD OF THE KST MANUFACTURING NUMBER 9610617. THE EVENT IS FILED UNDER INTERNAL KARL STORZ COMPLAINT ID: (B)(4).

    Description of Event or Problem · 0

    THE REPORTED EVENT HAPPENED IN CANADA. ACCORDING TO THE RECEIVED INFORMATION THE IMAGE OF A FLEXIBLE VIDEO CYSTOSCOPE HD-VIEW CAME UP WHEN THE SCOPE WAS PLUGGED IN BUT WHEN THEY WENT TO USE CAUTERIZATION WITH A BUGBEE ELECTRODE, AS SOON AS THE UROLOGIST ACTIVATES THE ELECTRODE, THE IMAGE CUT OUT. NO INJURY TO THE PATIENT, USER OR THIRD WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2847412 VIDEO FLEXIBLE CYSTOSCOPE FLEXIBLE VIDEO CYSTOSCOPE HD-VIEW FAJ KARL STORZ SE & CO. KG R11272VHK

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown