BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WATS3D BRUSH ESOPHAGEAL BIOPSY BRUSH

    MDR report key: 8374883 · Received February 26, 2019

    Report

    Report Number
    MW5084447
    Event Type
    Injury
    Date Received
    February 26, 2019
    Date of Event
    August 24, 2018
    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 UNDERWENT HERNIA REPAIR AND A NISSEN FUNDOPLICATION FOLLOWED IMMEDIATELY WITH UPPER ENDOSCOPY ESOPHAGEAL SCREENING AND BRUSH BIOPSY TESTING. THE HERNIA REPAIR HAD BEEN DELAYED FOR 5 YEARS IN THIS PATIENT. AFTER THE PHYSICIAN USED THE BRUSH TO COLLECT THE ESOPHAGEAL SPECIMEN, A TINY PERFORATION WAS NOTED IN THE ESOPHAGUS. THE PHYSICIAN NOTED THAT THE ESOPHAGEAL TISSUE WAS EXTREMELY FRIABLE AND THIN, AND ATTRIBUTED THESE CHANGES TO CHRONIC SYSTEMIC STEROID USE TO CONTROL RHEUMATOID ARTHRITIS, WHICH MADE THIS PATIENT VERY SUSCEPTIBLE TO PERFORATION. THE PATIENT DID NOT UNDERGO SAMPLING WITH FORCEPS BIOPSY. THE PHYSICIAN IMMEDIATELY REPAIRED THE DEFECT WITH SIMPLE CLOSURE AND A FOLLOW-UP BARIUM SWALLOW THE NEXT DAY DID NOT SHOW ANY LEAKAGE OR DEFECT. THE PATIENT COMPLETELY RECOVERED AND WAS DISCHARGED WITHOUT ANY SEQUELA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    162223 WATS3D BRUSH ESOPHAGEAL BIOPSY BRUSH BRUSH, BIOPSY, GENERAL AND PLASTIC SURGERY GEE ENDO-THERAPEUTICS, INC. EGD-160-006 323358

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Hospitalization