BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CYTOMAX II DOUBLE LUMEN CYTOLOGY BRUSH

    MDR report key: 23872401 · Received December 22, 2025

    Report

    Report Number
    1037905-2025-00858
    Event Type
    Malfunction
    Date Received
    December 22, 2025
    Date of Event
    November 25, 2025
    Report Date
    December 22, 2025
    Manufacturer
    WILSON-COOK MEDICAL INC (COOK ENDOSCOPY)
    Product Code
    FDX
    UDI-DI
    00827002226746
    PMA / PMN Number
    K192908
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION EVALUATION: A PRODUCT EVALUATION WAS NOT PERFORMED IN RESPONSE TO THIS REPORT BECAUSE THE PRODUCT SAID TO BE INVOLVED WAS NOT PROVIDED TO COOK FOR EVALUATION. THE REPORT COULD NOT BE CONFIRMED. THE DEVICE HISTORY RECORD FOR THE LOT NUMBER SAID TO BE INVOLVED WAS REVIEWED. A DISCREPANCY OR ANOMALY WAS NOT OBSERVED WITH THE PRODUCT THAT WAS RELEASED FOR DISTRIBUTION. INVESTIGATION CONCLUSION: A CORRECTIVE ACTION (CAPA) HAS BEEN INITIATED TO REDUCE OCCURRENCES OF BRUSH TIP/COIL SPRING DETACHMENT FOR CYTOLOGY BRUSH DEVICES. THE PRODUCT SAID TO BE INVOLVED IS INCLUDED IN THE SCOPE OF THE CORRECTIVE ACTIONS. PRIOR TO DISTRIBUTION, ALL CYTOMAX II DOUBLE LUMEN CYTOLOGY BRUSHES ARE SUBJECTED TO A VISUAL INSPECTION AND FUNCTIONAL TESTING TO ENSURE DEVICE INTEGRITY. A REVIEW OF THE DEVICE HISTORY RECORD CONFIRMED THAT THE LOT SAID TO BE INVOLVED MET ALL MANUFACTURING REQUIREMENTS PRIOR TO SHIPMENT. CORRECTIVE ACTION: A CORRECTIVE ACTION (CAPA) WAS INITIATED TO FURTHER INVESTIGATE DEVICE FAILURE DUE TO BRUSH TIP/COIL SPRING DETACHMENT. THE PRODUCT SAID TO BE INVOLVED IS INCLUDED IN THE SCOPE OF THE CORRECTIVE ACTION. A REVIEW OF THE COMPLAINT HISTORY WAS CONDUCTED. BASED ON THIS REVIEW, THE LIKELIHOOD OF THIS TYPE OF REPORT IS RARE. QUALITY ASSURANCE WILL CONTINUE TO MONITOR FOR COMPLAINT TRENDS.

    Description of Event or Problem · 0

    DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY [ERCP], THE PHYSICIAN USED A COOK CYTOMAX II DOUBLE LUMEN CYTOLOGY BRUSH. IT WAS REPORTED [THAT] DURING SAMPLE COLLECTION, 1.5 CM OF THE TIP OF THE [DEVICE] DETACHED FROM THE BRUSH AND REMAINED INSIDE THE PATIENT'S BILE DUCT. A SECTION OF THE DEVICE WAS TEMPORARILY LEFT INSIDE THE PATIENT¿S BODY. THE TIP WAS FOUND AND REMOVED FROM THE PATIENT IN A SEPARATE PROCEDURE ON (B)(6) 2025. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY FURTHER ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1716558 CYTOMAX II DOUBLE LUMEN CYTOLOGY BRUSH ENDOCSOCPIC CYTOLOGY BRUSH FDX WILSON-COOK MEDICAL INC (COOK ENDOSCOPY) G22674 W4880787 00827002226746

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Male UNKNOWN ENDOSCOPE MAKE AND MODEL