BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CYTOMAX II DOUBLE LUMEN CYTOLOGY BRUSH

    MDR report key: 20075792 · Received August 27, 2024

    Report

    Report Number
    1037905-2024-00491
    Event Type
    Malfunction
    Date Received
    August 27, 2024
    Date of Event
    July 30, 2024
    Report Date
    August 26, 2024
    Manufacturer
    WILSON-COOK MEDICAL INC
    Product Code
    FDX
    UDI-DI
    10827002226743
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION G: PMA/510(K):K192908. INVESTIGATION EVALUATION: THE PRODUCT SAID TO BE INVOLVED WAS RETURNED IN A WHITE PLASTIC BAG. PROVIDED WITH THE RETURN WAS AN OPEN POUCH FROM THE LOT NUMBER PROVIDED IN THE REPORT. THE LABEL MATCHES THE PRODUCT RETURNED. OUR LABORATORY EVALUATION OF THE PRODUCT SAID TO BE INVOLVED CONFIRMED THE REPORT BASED ON THE CONDITION OF THE RETURNED DEVICE. ONLY THE CATHETER AND DRIVE WIRE TO BRUSH ASSEMBLY WAS INCLUDED IN THE RETURN. THE DETACHED BRUSH TIP/COIL SPRING WAS NOT INCLUDED AND THEREFORE A FULL EVALUATION WAS NOT POSSIBLE. DURING A CLOSE VISUAL EXAMINATION OF THE DEVICE SOLDER WAS OBSERVED AT THE DISTAL END OF THE DRIVE WIRE. A PRODUCT-SPECIFIC DISCREPANCY THAT COULD HAVE CAUSED OR CONTRIBUTED TO THIS OBSERVATION WAS NOT OBSERVED DURING OUR LABORATORY ANALYSIS. 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: OUR EVALUATION OF THE RETURNED DEVICE CONFIRMED THE REPORT. 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 REVIEW OF THE COMPLAINT HISTORY WAS CONDUCTED. THE LIKELIHOOD OF OCCURRENCE IS CONSIDERED RARE. A CORRECTIVE ACTION HAS BEEN INITIATED IN AN EFFORT TO REDUCE OCCURRENCES OF THIS NATURE. THIS PRODUCT IS INCLUDED IN THE SCOPE OF THIS CORRECTIVE ACTION. QUALITY ASSURANCE WILL CONTINUE TO MONITOR FOR COMPLAINT TRENDS AND REASSESS THE RISK ASSESSMENT RESULTS AS POST MARKET FEEDBACK CONTINUES TO BECOME AVAILABLE.

    Description of Event or Problem · 0

    IN PREPARATION FOR A PROCEDURE, THE USER SELECTED A COOK CYTOMAX II DOUBLE LUMEN CYTOLOGY BRUSH. IT WAS REPORTED THAT THE USER OPENED THE PACKAGE AND [WAS] READY TO OBTAIN THE SAMPLE BUT FOUND THE BRUSH TIP BROKEN. IT IS THE SEPARATION OF THE CELL BRUSH HEAD FROM THE INSTRUMENT, AND NOW THE HEAD END CAN NOT BE FOUND. USER FOUND THAT THE HEAD END WAS ONLY CONNECTED TO ONE POINT WHEN DISASSEMBLED, AND THE INSTRUMENT WAS BROKEN WHEN IT WAS TAKEN OUT. THIS OCCURRED PRIOR TO PATIENT CONTACT; THERE WAS NO IMPACT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1218590 CYTOMAX II DOUBLE LUMEN CYTOLOGY BRUSH FDX ENDOSCOPIC CYTOLOGY BRUSH FDX WILSON-COOK MEDICAL INC G22674 W4787117 10827002226743

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Male OLYMPUS TJF-260V ENDOSCOPE