BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYTOMAX II DOUBLE LUMEN CYTOLOGY BRUSH

    MDR report key: 15789174 · Received November 14, 2022

    Report

    Report Number
    1037905-2022-00629
    Event Type
    Injury
    Date Received
    November 14, 2022
    Date of Event
    October 28, 2022
    Report Date
    January 6, 2023
    Manufacturer
    WILSON-COOK MEDICAL INC
    Product Code
    FDX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    510K: K192908. 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: WE COULD NOT CONDUCT A COMPLETE INVESTIGATION BECAUSE THE PRODUCT SAID TO BE INVOLVED WAS NOT RETURNED FOR EVALUATION. A DEFINITIVE CAUSE FOR THE REPORTED OBSERVATION COULD NOT BE DETERMINED. THE INSTRUCTIONS FOR USE INCLUDING THE FOLLOWING: "AFTER OBTAINING SPECIMEN, RETRACT BRUSH INTO SHEATH." FAILURE TO RETRACT THE BRUSH INTO THE SHEATH MAY CAUSE EXCESS FORCE ON THE DEVICE DURING REMOVAL FROM THE SCOPE. PRIOR TO DISTRIBUTION, ALL FUSION CYTOLOGY BRUSHES ARE SUBJECTED TO A VISUAL INSPECTION AND FUNCTIONAL TESTING TO ENSURE DEVICE INTEGRITY. A REVIEW OF THE POSSIBLE DEVICE HISTORY RECORDS CONFIRMED THAT THE LOTS 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. CORRECTIVE ACTION IS NOT WARRANTED AT THIS TIME BASED ON THE QUALITY ENGINEERING RISK ASSESSMENT. QUALITY ASSURANCE WILL CONTINUE TO MONITOR FOR COMPLAINT TRENDS AND REASSESS THE RISK ASSESSMENT RESULTS AS POST MARKET FEEDBACK CONTINUES TO BECOME AVAILABLE.

    Additional Manufacturer Narrative · 0

    INVESTIGATION EVALUATION: THE PRODUCT SAID TO BE INVOLVED WAS RETURNED IN 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. THE DEVICE'S COIL SPRING TIP WAS RETURNED, HOWEVER THE REST OF THE DEVICE WAS NOT INCLUDED WITH THE RETURN. THE RETURNED COIL SPRING TIP MEASURED APPROXIMATELY 16 MM LONG AND PRESENTED WITH A MINOR BEND. THE BRUSH WIRE IS NOT PRESENT INSIDE THE COIL SPRING TIP. 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: A DEFINITIVE CAUSE FOR THE REPORTED OBSERVATION COULD NOT BE DETERMINED BECAUSE THE CONDITION OF THE PRODUCT SAID TO BE INVOLVED PROHIBITED A COMPLETE EVALUATION. WITHOUT THE BRUSH AT THE DISTAL END OF THE DEVICE, THE JOINT BETWEEN THE BRUSH AND THE COIL SPRING TIP COULD NOT BE FULLY EVALUATED. A DISCREPANCY OR ANOMALY THAT COULD HAVE CONTRIBUTED TO THE REPORTED OBSERVATION WAS NOT OBSERVED DURING OUR LABORATORY ANALYSIS OF THE RETURNED PRODUCT. THE INSTRUCTIONS FOR USE INCLUDING THE FOLLOWING: "AFTER OBTAINING SPECIMEN, RETRACT BRUSH INTO SHEATH." FAILURE TO RETRACT THE BRUSH INTO THE SHEATH MAY CAUSE EXCESS FORCE ON THE DEVICE DURING REMOVAL FROM THE SCOPE. PRIOR TO DISTRIBUTION, ALL FUSION 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. CORRECTIVE ACTION IS NOT WARRANTED AT THIS TIME BASED ON THE QUALITY ENGINEERING RISK ASSESSMENT. 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

    DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY, THE PHYSICIAN USED A COOK CYTOMAX II DOUBLE LUMEN CYTOLOGY BRUSH. IT WAS REPORTED THAT THE USERS WERE COLLECTING BRUSHING SAMPLES AND THE METAL TIP OF THE BRUSH CATHETER FELL OFF AND WAS RETAINED WITHIN THE BILE DUCT. THERE WERE NO CONCERNS NOTED UPON VISUAL INSPECTION OF THE ITEM BEFORE USE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE DETACHED PORTION OF THE CYTOLOGY BRUSH WAS RETRIEVED WITH AN EXTRACTION BALLOON DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1783776 CYTOMAX II DOUBLE LUMEN CYTOLOGY BRUSH FDX ENDOSCOPIC CYTOLOGY BRUSH FDX WILSON-COOK MEDICAL INC W4615866

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Male Required Intervention ENDOSCOPE - OLYMPUS, UNKNOWN MODEL