BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    C-MAC VIDEO LARYNGOSCOPE MAC #3

    MDR report key: 21013194 · Received December 24, 2024

    Report

    Report Number
    9610617-2024-00540
    Event Type
    Malfunction
    Date Received
    December 24, 2024
    Date of Event
    September 1, 2024
    Report Date
    February 3, 2025
    Manufacturer
    KARL STORZ SE & CO. KG
    Product Code
    CCW
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE AFFECTED DEVICE HAS BEEN REQUESTED FOR INVESTIGATION BY THE MANUFACTURER. THE DEVICE WAS NOT YET RETURNED FOR INVESTIGATION. THE EVENT IS FILED UNDER INTERNAL KARL STORZ COMPLAINT ID: (B)(4).

    Additional Manufacturer Narrative · 0

    RESULT OF INVESTIGATION: SINCE THE PRODUCT WAS NOT SENT TO KST FOR INSPECTION AND THERE IS NO BATCH NUMBER, NO DETAILED INSPECTION COULD BE CARRIED OUT. BASED ON THE ERROR REPORTED BY THE CUSTOMER (LOOSE CONTACT) AND ON THE BASIS OF COMPARABLE COMPLAINTS, OUR OWN EXPERIENCE HAS LED US TO THE MOST LIKELY CONCLUSION THAT THE ADHESIVE AT THE TIP OF THE C-MAC BLADE MAY HAVE WORN OUT DUE TO THE REMANUFACTURING PROCESS, CAUSING LIQUID TO ENTER THE BLADE, WHICH AFFECTS THE ELECTRONICS AND CAN CAUSE THE LED TO FAIL/DIMINISH IN INTENSITY. FURTHERMORE, THE IMAGE SENSOR CAN BE AFFECTED BY THE INGRESS OF LIQUID AND CAN SHOW IMAGE INTERFERENCE/FAILURE, AND A LOOSE CONTACT CAN ALSO BE THE RESULT. FURTHERMORE, THE CAUSE COULD ALSO BE DROP DAMAGE TO A LOOSE CONTACT OR IT COULD BE A FAULT OF ANOTHER COMPONENT SUCH AS THE CABLE OR SCREEN THAT CAN BE CONNECTED. THE IFU ALSO DESCRIBES THAT A FUNCTIONAL AND VISUAL TEST MUST BE CARRIED OUT BEFORE USE. THE EVENT IS FILED UNDER INTERNAL KARL STORZ COMPLAINT ID: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING THE PROCEDURE THE LIGHT AND THE IMAGE OF THE VIDEO LARYNGOSCOPE FAILED. NO HARM TO PATIENT, USER OR THIRD REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2190926 C-MAC VIDEO LARYNGOSCOPE MAC #3 C-MAC VIDEO LARYNGOSCOPE MAC #3 CCW KARL STORZ SE & CO. KG 8404AXC

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown