BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFINITY CYTOLOGY BRUSH

    MDR report key: 7488096 · Received May 4, 2018

    Report

    Report Number
    1528319-2018-00013
    Event Type
    Malfunction
    Date Received
    May 4, 2018
    Report Date
    May 4, 2018
    Manufacturer
    UNITED STATES ENDOSCOPY GROUP, INC.
    Product Code
    FDX
    UDI-DI
    00816765012185
    PMA / PMN Number
    K924104
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DISPOSABLE INFINITY CYTOLOGY BRUSH IS INTENDED TO BE USED TO RETRIEVE CYTOLOGICAL CELL SAMPLES IN THE GASTROINTESTINAL TRACT. FOLLOWING US ENDOSCOPY'S RECEIPT OF THE EVENT, A TWO-YEAR REVIEW OF INFINITY CYTOLOGY BRUSH COMPLAINTS WAS PERFORMED AND FOUND NO OTHER REPORTS OF BRUSH HEAD DETACHMENT. US ENDOSCOPY REQUESTED THE DEVICE BE RETURNED FOR EVALUATION; HOWEVER, THE FACILITY DISPOSED OF THE BRUSH HEAD FOLLOWING THE EVENT. THE LOT NUMBER OF THE SUBJECT DEVICE WAS UNKNOWN BY USER FACILITY PERSONNEL. THROUGH A REVIEW OF ORDER HISTORY, US ENDOSCOPY HAS DETERMINED INFINITY CYTOLOGY BRUSH LOT NUMBERS 1718053 AND 1802792 WERE THE ONLY LOTS SENT TO THE FACILITY. THE DEVICE HISTORY RECORDS FOR THESE LOTS WERE REVIEWED AND CONFIRMED THE DEVICES WERE MANUFACTURED TO SPECIFICATION. THERE HAVE BEEN NO OTHER COMPLAINTS ASSOCIATED WITH DEVICES FROM THESE LOTS. THE DEVICE'S INSTRUCTIONS FOR USE STATE: "THE BRUSH SHOULD NEVER BE FORCED THROUGH THE ENDOSCOPE'S CHANNEL. IF RESISTANCE IS MET DUE TO EXCESS ANGULATION OF THE ENDOSCOPE, IT MAY BE NECESSARY TO DECREASE THE ANGULATION TO ALLOW PASSAGE OF THE BRUSH. PRIOR TO CLINICAL USE, FAMILIARIZE YOURSELF WITH THE DEVICE AND READ ALL THE INSTRUCTIONS FOR USE. INSPECT THE PACKAGE FOR SHIPPING OR HANDLING DAMAGE. IF DAMAGE IS EVIDENT, DO NOT USE THIS DEVICE AND CONTACT YOUR PRODUCT SPECIALIST. FULLY RETRACT AND DEPLOY THE SPOOL HANDLE AND THUMB RING 3-4 TIMES TO ENSURE THE DEVICE FUNCTIONS PROPERLY AND IS NOT DAMAGED. IF DAMAGE IS EVIDENT, DO NOT USE THIS DEVICE." US ENDOSCOPY OFFERED IN-SERVICE TRAINING, HOWEVER THE USER FACILITY HAS DECLINED.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT DURING AN EGD PROCEDURE, THE DISTAL BRUSH HEAD BECAME DETACHED FROM THE INFINITY CYTOLOGY BRUSH DEVICE. THE BRUSH HEAD WAS IMMEDIATELY RETRIEVED WITH NO REPORT OF PATIENT HARM DUE TO THE DETACHED COMPONENT NOR THE RETRIEVAL. THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    331728 INFINITY CYTOLOGY BRUSH CYTOLOGY BRUSH FDX UNITED STATES ENDOSCOPY GROUP, INC. 00711499 00816765012185

    Patients

    Seq Age Sex Outcome Treatment
    1