BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WATS3D BRUSH

    MDR report key: 8374941 · Received February 26, 2019

    Report

    Report Number
    MW5084452
    Event Type
    Injury
    Date Received
    February 26, 2019
    Date of Event
    January 25, 2019
    Report Date
    February 22, 2019
    Manufacturer
    ENDO-THERAPEUTICS, INC
    Product Code
    GEE
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE PATIENT, WHO HAS A HISTORY OF LONG SEGMENT BARRETT¿S ESOPHAGUS (10-15 CM), UNDERWENT SURVEILLANCE WITH UPPER ENDOSCOPY WITH FORCEPS BIOPSY AND BRUSH BIOPSY. AFTER THE FORCEPS BIOPSIES WERE OBTAINED, THE BRUSH BIOPSY WAS INTRODUCED INTO THE CHANNEL OF THE ENDOSCOPE. WHILE THE PHYSICIAN HELD THE ENDOSCOPE, THE PHYSICIAN¿S ASSISTANT MOVED THE BRUSH UP AND DOWN TO SAMPLE THE ESOPHAGUS. THE ESOPHAGUS WAS NOTED TO BE VERY TORTUOUS, AND AT A SEGMENT OF THE ESOPHAGUS, WHICH WAS FELT TO BE SHARPLY ANGULATED AND NOT ENTIRELY VISIBLE ON THE MONITOR, THE ESOPHAGUS WAS PERFORATED. THE PATIENT WAS ADMITTED TO THE HOSPITAL AND THE FOLLOWING DAY, THE PERFORATION WAS SURGICALLY REPAIRED. THE PATIENT RECOVERED AND WAS DISCHARGED SEVERAL DAYS LATER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    162233 WATS3D BRUSH ESOPHAGEAL BIOPSY BRUSH GEE ENDO-THERAPEUTICS, INC EGD-160-006 351132

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Hospitalization