BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FUSION CYTOLOGY BRUSH

    MDR report key: 19871479 · Received July 31, 2024

    Report

    Report Number
    1037905-2024-00424
    Event Type
    Malfunction
    Date Received
    July 31, 2024
    Date of Event
    July 3, 2024
    Report Date
    July 31, 2024
    Manufacturer
    WILSON-COOK MEDICAL INC
    Product Code
    FDX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION G: PMA/510(K):K192908. INVESTIGATION EVALUATION: THE PRODUCT SAID TO BE INVOLVED WAS RETURNED IN A CLEAR PLASTIC BAG. PROVIDED WITH THE RETURN WAS AN UNMARKED POUCH WITH A MICRO LABEL FROM THE LOT NUMBER PROVIDED ATTACHED. OUR LABORATORY EVALUATION OF THE PRODUCT SAID TO BE INVOLVED CONFIRMED THE REPORT. THE DEVICE WAS RETURNED WITH THE BRUSH ADVANCED FULLY AND COIL SPRING TIP DETACHED FROM THE DRIVE WIRE/BRUSH ASSEMBLY. THE DETACHED COIL SPRING TIP MEASURED APPROXIMATELY 13 MM LONG. SOLDER IS PRESENT ON THE DISTAL END OF THE DRIVE WIRE AND PROXIMAL END OF THE COIL SPRING. AN UNKNOWN DARK SUBSTANCE WAS ALSO OBSERVED THROUGHOUT THE CATHETER AND ON THE BRUSH. A LAB MEETING WAS HELD WITH PRODUCTION LEADERSHIP AND MANUFACTURING ENGINEERING ON 30JUL2024, AND THE DEVICE WAS EXAMINED. DURING THE LAB MEETING IT WAS DETERMINED THAT THE COIL SPRING TIP TO DRIVE WIRE JOINT HAD THE APPROPRIATE AMOUNT OF SOLDER AND DID NOT APPEAR TO BE OVER BUFFED. WE WERE UNABLE TO DETERMINE A CAUSE FOR THE COIL SPRING DETACHING FROM THE BRUSH. A PRODUCT DISCREPANCY OR ANOMALY THAT COULD HAVE CONTRIBUTED TO THE REPORTED OCCURRENCE WAS NOT OBSERVED. 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 DEFINITIVE CAUSE FOR THIS OBSERVATION COULD NOT BE DETERMINED BECAUSE THE ACTUAL USE CONDITIONS COULD NOT BE DUPLICATED IN THE LABORATORY SETTING. DUE TO A VARIETY OF CLINICAL CONDITIONS SUCH AS PATIENT ANATOMY, ENDOSCOPE POSITION OR PROGRESSION OF DISEASE STATE, WE COULD NOT REPRODUCE THE ACTUAL CONDITIONS OF PRODUCT USAGE DURING OUR LABORATORY ANALYSIS. THIS LIMITS OUR ABILITY TO CONCLUSIVELY DETERMINE A CAUSE. 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 FUSION CYTOLOGY BRUSH. IT WAS REPORTED THAT THE TIP OF THE BRUSH HAS COME OFF. AFTER USUAL USE, THE TIP STILL HUNG VERY LOOSELY AFTER REMOVING THE INSTRUMENT, BUT THEN BROKE OFF COMPLETELY. FORTUNATELY, NO PARTS REMAINED IN THE PATIENT. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES 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
    883913 FUSION CYTOLOGY BRUSH FDX ENDOSCOPIC CYTOLOGY BRUSH FDX WILSON-COOK MEDICAL INC W4811186

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown OLYMPUS DUODENOSCOPE TJF.