BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFINITY

    MDR report key: 4717864 · Received April 15, 2015

    Report

    Report Number
    4717864
    Event Type
    Malfunction
    Date Received
    April 15, 2015
    Date of Event
    April 6, 2015
    Report Date
    April 15, 2015
    Manufacturer
    US ENDOSCOPY GROUP, INC
    Product Code
    FDX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    GA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    MD WAS USING US ENDOSCOPY BRUSH IN PATIENT AND THE END OF BRUSH BROKE OFF INSIDE PATIENT. BRUSH WAS RETRIEVED.MANUFACTURER RESPONSE FOR INFINITY SAMPLING DEVICE, INFINITY ERCP SAMPLING BRUSH. (PER SITE REPORTER).======================WITHOUT FURTHER DELAY, BELOW IS A SHORT LIST OF QUESTIONS RELATE TO THE INFINITY ERCP SAMPLING BRUSH.HOW IS THE PATIENT?WAS SHORT OR LONG WIRE EXCHANGE TECHNIQUE USED?WHERE WAS THE STRICTURE LOCATED ( PROX-MID-DISTAL CBD,L/R INTRAHEPATIC, PANCREATIC HEAD, TAIL, OR BODY)?DID YOU OBSERVED ANY ISSUES WITH THE BRUSH HEAD ALIGNMENT, PRIOR TO OR DURING USE?WHAT BRUSHING TECHNIQUE WAS BEING USED (ACTUATING THE FINGER RING, OR PUSH CATHETER BACK AND FORTH)? HOW MANY BRUSH CYCLES BEFORE SEPARATION?WHEN DURING THE BRUSHING PORTION OF THE CASE DID YOU OBSERVE THE BRUSH SEPARATION?DID YOU OBSERVE THE ATTACHMENT POINT OF THE MECHANICAL CONNECTOR (ATTACHED TO THE BRUSH OR ATTACHED TO THE CATHETER PORTION OF THE DEVICE)?PLEASE DESCRIBE YOUR OVERALL EXPERIENCE WITH THIS DEVICE PRIOR TO THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    252677 INFINITY ENDOSCOPIC CYTOLOGY BRUSH FDX US ENDOSCOPY GROUP, INC 00711652 *

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR