BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CCU,MODULAR,IMAGE1 S X-LINK,US

    MDR report key: 20667352 · Received November 12, 2024

    Report

    Report Number
    2027009-2024-00448
    Event Type
    Malfunction
    Date Received
    November 12, 2024
    Date of Event
    October 31, 2024
    Report Date
    December 4, 2024
    Manufacturer
    KARL STORZ IMAGING
    Product Code
    FET
    UDI-DI
    04048551356562
    PMA / PMN Number
    K160044
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED TO OUR US FACILITY ON NOV-18-2024, AND WILL LATER BE FORWARDED TO THE MANUFACTURING SITE FOR INVESTIGATION. SHOULD RELEVANT ADDITIONAL INFORMATION / INVESTIGATION RESULTS BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED UNSOLICITED. THIS EVENT IS FILED UNDER INTERNAL COMPLAINT ID: (B)(4).

    Additional Manufacturer Narrative · 0

    PER EVALUATION BY THE MANUFACTURING SITE: THE CUSTOMER'S COMPLAINT WAS VERIFIED. THE TC301US CCU FAILED TO LINK TO TC201US/TC200US TEST FIXTURES. A FUNCTIONAL TEST CONFIRMED THE CUSTOMER'S COMPLAINT. TROUBLESHOOTING RESOLVED THE ISSUE BY REPLACING THE POWER SUPPLY (KSI PART#: 053070-05 REV. BA). WITH A TEST FIXTURE POWER SUPPLY INSTALLED THE CCU WAS BURNED-IN OVERNIGHT WITHOUT ISSUE. KARL STORZ DOES NOT HAVE ACCESS TO THE POWER SUPPLY SCHEMATIC, SO A SPECIFIC PART COULD NOT BE IDENTIFIED. ULTIMATELY, A POWER SUPPLY REPLACEMENT IS REQUIRED TO ADDRESS THE CUSTOMER'S ISSUE. POWER SUPPLY INFO: (B)(6) PART#: BPC000129 REV. E1: SERIAL NUMBER: (B)(6). THIS EVENT IS FILED UNDER INTERNAL COMPLAINT ID: (B)(4).

    Additional Manufacturer Narrative · 0

    THE DEVICE WILL BE FORWARDED TO THE MANUFACTURING SITE FOR INVESTIGATION. SHOULD RELEVANT ADDITIONAL INFORMATION / INVESTIGATION RESULTS BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED UNSOLICITED. THIS EVENT IS FILED UNDER INTERNAL COMPLAINT ID: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A CYSTOSCOPY PROCEDURE ON (B)(6) 2024, THE DEVICE GAVE AN ERROR AND NOT RESPONDING. THEY WERE ABLE TO COMPLETE THE PROCEDURE USING A SINGLE-USE SCOPE WITHOUT ANY PATIENT IMPACT. HOWEVER, THIS ISSUE CAUSED A DELAY TO THE PROCEDURE FOR ABOUT 30 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    976605 CCU,MODULAR,IMAGE1 S X-LINK,US CCU,MODULAR FET KARL STORZ IMAGING TC301US 04048551356562

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Female