BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CCU,MODULAR,X-LINK,INTL,CE

    MDR report key: 20588056 · Received November 1, 2024

    Report

    Report Number
    2027009-2024-00412
    Event Type
    Malfunction
    Date Received
    November 1, 2024
    Date of Event
    October 3, 2024
    Report Date
    December 10, 2024
    Manufacturer
    KARL STORZ IMAGING
    Product Code
    FET
    PMA / PMN Number
    K131953
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PER EVAULUATION CONDUCTED BY THE MANUFACTURE SITE: PRODUCT INSPECTION: MATERIAL: TC301. SERIAL NUMBER: (B)(6). THE CUSTOMER'S COMPLAINT WAS VERIFIED. THE TC301 CCU WOULD NOT BE DETECTED BY TC201 TEST FIXTURES. A FUNCTIONAL TEST CONFIRMED THE CUSTOMER'S COMPLAINT. TROUBLESHOOTING FOUND THAT THE TC301 WASN'T FULLY BOOTING UP BECAUSE P5V0A WAS SHORTED TO GROUND. THE SHORT WAS ISOLATED TO AN INTERNAL COMPONENT FAILURE OF U1 (KSI PART # 009243-00). AFTER THE REMOVAL OF U1, THE SHORT WAS NO LONGER PRESENT. TO ENSURE NO FURTHER LATENT FAILURES, THE MOTHERBOARD SHOULD BE REPLACED. ULTIMATELY, THE CUSTOMER'S ISSUE WAS CAUSED BY U1 COMPONENT FAILURE ON MOTHERBOARD 062705-19BA _ SERIAL NUMBER: (B)(6). PROCEDURE COUNT: 214 _ RUN-TIME: 1182 HOURS & 37 MIN. THIS EVENT IS FILED UNDER INTERNAL COMPLAINT ID (B)(4).

    Additional Manufacturer Narrative · 0

    CORRECTION ON ROUTING NUMBER FOR SUPPLEMENT 2. THIS EVENT IS FILED UNDER INTERNAL COMPLAINT ID (B)(4).

    Additional Manufacturer Narrative · 0

    CORRECTION WAS MADE IN SECTION B2. THE SUBMISSION DATE FOR 24_412_SUP1 WAS DECEMBER 04, 2024.

    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 FLEXIBLE VIDEO CYSTOSCOPY ON (B)(6) 2024, THE DEVICE STOPPED WORKING AND DID NOT PROVIDE AN IMAGE. CUSTOMER GRABBED A BACK-UP DEVICE TO COMPLETE THE PROCEDURE WITHOUT ANY PATIENT IMPACT. HOWEVER THE ISSUE CAUSED A DELAY OF ABOUT 5-10 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    632555 CCU,MODULAR,X-LINK,INTL,CE CCU,MODULAR,X-LINK,INTL,CE FET KARL STORZ IMAGING TC301

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown