BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BRUSH, CLEANING, DBL, DIF ENDS

    MDR report key: 7591744 · Received June 12, 2018

    Report

    Report Number
    1417592-2018-00057
    Event Type
    Malfunction
    Date Received
    June 12, 2018
    Date of Event
    May 1, 2018
    Report Date
    June 12, 2018
    Manufacturer
    MEDLINE INDUSTRIES INC.
    Product Code
    MNL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT DURING AN EGD PROCEDURE, THE SEPARATED BRUSH HEAD THAT WAS USED TO CLEAN THE ENDOSCOPE FELL OUT OF THE ENDOSCOPE AND INTO THE PATIENT'S STOMACH. IT WAS NOT IDENTIFIED AT WHAT POINT IN THE EGD PROCEDURE THIS OCCURRED. REPORTEDLY, THE PHYSICIAN WAS REQUIRED TO REMOVE THE SEPARATED BRUSH HEAD FROM THE PATIENT'S STOMACH WITH A NET. NO FURTHER INCIDENT REPORTED. THE PATIENT WAS NOT UNDER GENERAL ANESTHESIA AT THE TIME OF THE INCIDENT. THE PROCEDURE DID NOT LAST LONGER THAN EXPECTED. NO SERIOUS INJURY OR FOLLOW-UP CARE REPORTED. THERE WAS NO SAMPLE AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION. DUE TO THE NEED FOR MEDICAL INTERVENTION TO RETRIEVE THE SEPARATED BRUSH HEAD, AND IN AN ABUNDANCE OF CAUTION, THIS MEDWATCH IS BEING FILED. IF ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN EGD PROCEDURE, THE SEPARATED BRUSH HEAD THAT WAS USED TO CLEAN THE ENDOSCOPE FELL OUT OF THE ENDOSCOPE AND INTO THE PATIENT'S STOMACH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    436595 BRUSH, CLEANING, DBL, DIF ENDS MNL MEDLINE INDUSTRIES INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention