BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CMOS VIDEO RHINO-LARYNGOSCOPE

    MDR report key: 21516227 · Received March 4, 2025

    Report

    Report Number
    9610617-2025-00282
    Event Type
    Malfunction
    Date Received
    March 4, 2025
    Report Date
    June 30, 2025
    Manufacturer
    KARL STORZ SE & CO. KG
    Product Code
    EOB
    UDI-DI
    04048551402405
    PMA / PMN Number
    K182186
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE IN QUESTION WAS RETURNED TO THE MANUFACTURER. THIS INFORMATION IS REFLECTED IN SECTION D9. THE EVALUATION IS ANTICIPATED, BUT NOT YET BEGUN. THE INVESTIGATION WILL BE PERFORMED BY A DESIGNATED KARL STORZ EMPLOYEE. THE EVENT IS FILED UNDER INTERNAL KARL STORZ COMPLAINT ID: (B)(4).

    Additional Manufacturer Narrative · 0

    FINAL RESULTS OF INVESTIGATION: A VISUAL AND FUNCTIONAL TEST WAS CARRIED OUT ON THE ENDOSCOPE. THE HANDLE AND THE ANGLE COVER SHOW SIGNS OF WEAR. THE DISTAL END HAS A KNOCK AND THE BUSHING IS LEAKING. THE SENSOR AND THE INTERFACE BOARD ARE DAMAGED. THE ERROR DESCRIBED BY THE CUSTOMER "NO IMAGE" COULD BE CONFIRMED. THE STATEMENT THAT THE LEAK IS SUFFICIENT COULD NOT BE CONFIRMED. THE ENDOSCOPE DID NOT PASS THE LEAK TEST. THE CAUSE OF THE MISSING IMAGE IS A HIT TO THE DISTAL END WHICH DAMAGED THE SENSOR AND CAUSED THE BUSHING'S ADHESIVE CONNECTION TO COME LOOSE AND LEAK. FOR THIS REASON, A USER MISUSE ERROR IS TO BE ASSUMED WHICH LED TO THE MISSING IMAGE. THE ABOVE CONDUCTED INVESTIGATIONS DID NOT REVEAL A ROOT CAUSE RELATED TO THE LABELLING, THE DEVICE OR ITS HISTORY. ALL PRODUCTION RELATED QUALITY CHECKS WERE PASSED, AND NO NON-CONFORMITIES WERE IDENTIFIED IN THE DEVICES MANUFACTURING RECORDS. THE EVENT IS FILED UNDER INTERNAL KARL STORZ COMPLAINT ID: (B)(4).

    Additional Manufacturer Narrative · 0

    AN INCORRECT ADDRESS WAS PROVIDED IN SECTION G1 IN THE INITIAL REPORT. THIS SUPPLEMENTAL REPORT IS TO PROVIDE THE CORRECT CONTACT INFORMATION FOR THIS SECTION. THE EVENT IS FILED UNDER INTERNAL KARL STORZ COMPLAINT ID: (B)(4).

    Additional Manufacturer Narrative · 0

    ADDING AWARENESS DATE FOR 9610617-2025-00282 SUPPLEMENTAL #1, AS IT WAS SUBMITTED WITHOUT THE AWARENESS DATE. THE AWARENESS DATE SHOULD BE APRIL 14, 2025. THE EVENT IS FILED UNDER INTERNAL KARL STORZ COMPLAINT ID: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT NO IMAGE ON THE SCREEN (TRIED IN C-MAC MONITOR AND TELEPACK+), LEAKAGE TEST OK. NO SURGICAL DELAY OR PROLONGATION OF SURGERY. NO DEATH OR (UNANTICIPATED) SERIOUS DETERIORATION IN STATE OF HEALTH REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    473708 CMOS VIDEO RHINO-LARYNGOSCOPE CMOS VIDEO RHINO-LARYNGOSCOPE EOB KARL STORZ SE & CO. KG 11102CM 79899 04048551402405

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown