BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFINITY SAMPLING DEVICE

    MDR report key: 4071877 · Received August 12, 2014

    Report

    Report Number
    1528319-2014-00014
    Event Type
    Malfunction
    Date Received
    August 12, 2014
    Report Date
    August 8, 2014
    Manufacturer
    UNITED STATES ENDOSCOPY GROUP, INC.
    Product Code
    FDX
    PMA / PMN Number
    K103437
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DISPOSABLE INFINITY SAMPLING DEVICE IS INTENDED TO BE SUED TO RETRIEVE CYTOLOGICAL CELL SAMPLES IN THE GASTROINTESTINAL TRACT. THE DEVICE WAS NOT RETURNED FOR EVALUATION AND THE LOT NUMBER WAS NOT KNOWN. THE LOT HISTORY RECORDS FOR ALL LOTS WHICH HAD SHIPPED TO THE CUSTOMER WERE REVIEWED, AND THE MANUFACTURING METHODS AND INSPECTION WERE CONFIRMED ACCEPTABLE. THIS REPORT WILL BE UPDATED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    ON (B)(6) 2014, A COMPLAINT WAS RECEIVED REPORTING BRUSH HEAD DETACHMENT DURING A USE OF THE INFINITY SAMPLING DEVICE. IN FOLLOW UP COMMUNICATION, THE PHYSICIAN REPORTED THE PANCREATIC DUCT AND COMPLETING TWO TO THREE BRUSHING CYCLES PRIOR TO THE BRUSH HEAD BECOMING DETACHED AND REMAINING IN THE DISTAL DUCT. THE PHYSICIAN REPORTED NO ADDITIONAL SURGICAL OR MEDICAL TREATMENT WAS REQUIRED, AND NO COMPLICATIONS AS A RESULT OF THIS EVENT WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    478972 INFINITY SAMPLING DEVICE SAMPLING DEVICE FDX UNITED STATES ENDOSCOPY GROUP, INC. 00711652 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other