BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYTOMAX II DOUBLE LUMEN CYTOLOGY BRUSH

    MDR report key: 14273372 · Received May 4, 2022

    Report

    Report Number
    1037905-2022-00199
    Event Type
    Injury
    Date Received
    May 4, 2022
    Date of Event
    April 4, 2022
    Report Date
    May 2, 2022
    Manufacturer
    WILSON-COOK MEDICAL INC
    Product Code
    FDX
    UDI-DI
    10827002226743
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    510K: K192908. INVESTIGATION EVALUATION: A PRODUCT EVALUATION WAS PERFORMED ONLY BY THE PICTURES PROVIDED IN RESPONSE TO THIS REPORT BECAUSE THE PRODUCT SAID TO BE INVOLVED WAS NOT PROVIDED TO COOK FOR EVALUATION. THE REPORT WAS CONFIRMED WITH THE PICTURES PROVIDED. THE PHOTOS WERE X-RAY IMAGES WHICH SHOWED THE BROKEN BRUSH TIP INSIDE OF THE PATIENT. A PICTURE OF THE LOT NUMBER WAS NOT PROVIDED. WITHOUT THE PRODUCT OR SUBSTANTIAL EVIDENCE TO CONTRADICT THE COMPLAINT, IT IS CONSIDERED CONFIRMED BASED SOLELY ON THE PHOTOS PROVIDED AND STATEMENTS DESCRIBING THE EVENT. THE DEVICE HISTORY RECORD FOR THE DLB-35-1.5-S WAS REVIEWED. THE DLB-35-1.5-S DEVICE HISTORY RECORD CONTAINS A NONCONFORMANCE THAT COULD POTENTIALLY BE RELATED TO ¿PRODUCT¿S TIP WAS SEPARATED¿. THE DEVICE GOES THROUGH VARIOUS INSPECTIONS PRIOR TO LEAVING THE FACILITY. THESE INSPECTIONS WOULD HAVE REMOVED ANY NONCONFORMING DEVICES PRIOR TO DISTRIBUTION. 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.

    Description of Event or Problem · 0

    DURING AN ENDOSCOPIC PROCEDURE FOR CELL ACQUISITION, THE PHYSICIAN USED A CYTOMAX II DOUBLE LUMEN CYTOLOGY BRUSH. IT WAS REPORTED THAT THE PRODUCT'S CYTOLOGY BRUSH TIP WAS SEPARATED, DETACHED, IN THE PATIENT¿S HEPATIC DUCT. THEY USED A VARIETY OF PRODUCTS TO REMOVE THE TIP, BUT FAILED TO REMOVE IT AND ENDED THE PROCEDURE AFTER THEY PLACED AN ENBD-7-LIGUORY-RT NASAL BILIARY DRAINAGE SETS. THE PATIENT REQUIRED ADDITIONAL PROCEDURES TO REMOVE THE FOREIGN BODY DUE TO THIS OCCURRENCE, BUT WERE UNSUCCESSFUL IN REMOVING THE TIP AND REMAINED INSIDE THE PATIENT¿S BODY TO PASS NATURALLY. 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
    1218253 CYTOMAX II DOUBLE LUMEN CYTOLOGY BRUSH FDX ENDOSCOPIC CYTOLOGY BRUSH FDX WILSON-COOK MEDICAL INC W4552769 10827002226743

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown ENDOSCOPE - OLYMPUS TJF 260V