BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FUSION CYTOLOGY BRUSH

    MDR report key: 4021340 · Received July 9, 2014

    Report

    Report Number
    1037905-2014-00278
    Event Type
    Malfunction
    Date Received
    July 9, 2014
    Report Date
    June 9, 2014
    Manufacturer
    WILSON-COOK MEDICAL INC.
    Product Code
    FDX
    PMA / PMN Number
    K040324
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    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. A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE CONDUCTED BECAUSE THE LOT NUMBER WAS NOT PROVIDED. INVESTIGATION CONCLUSIONS: 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. DAMAGE TO THE TIP CAN OCCUR IF THE DEVICE EXPERIENCES EXCESSIVE PRESSURE DURING PRODUCT HANDLING SUCH AS CONTACT WITH A HARD MASS. PRIOR TO DISTRIBUTION, ALL FUSION CYTOLOGY BRUSHES ARE SUBJECTED TO A VISUAL INSPECTION AND FUNCTIONAL TEST TO ENSURE PROPER WORKABILITY AND DEVICE INTEGRITY. 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 · 1

    DURING THE PROCEDURE, A COOK FUSION CYTOLOGY BRUSH WAS USED. THE PHYSICIAN REPORTED PROBLEMS WITH THE CYTOLOGY BRUSH. THE BRUSH DETACHED INSIDE THE PATIENT. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT'S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURE 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
    400801 FUSION CYTOLOGY BRUSH FDX, BRUSH, CYTOLOGY FOR ENDOSCOPE FDX WILSON-COOK MEDICAL INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 ENDOSCOPE: MODEL # UNK