BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DAR

    MDR report key: 8960234 · Received September 4, 2019

    Report

    Report Number
    3004904811-2019-00033
    Event Type
    Injury
    Date Received
    September 4, 2019
    Date of Event
    July 18, 2019
    Report Date
    September 4, 2019
    Manufacturer
    COVIDIEN LP BARRX
    Product Code
    GEI
    PMA / PMN Number
    K142364
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER, DURING A RADIO FREQUENCY ABLATION OF BARRETT'S ESOPHAGUS EXTENDING UP FROM ESOPHAGOGASTRIC JUNCTION (EGJ), THEY WERE SCRAPING A LITTLE TOO AGGRESSIVELY IN THE COAGULUM FROM THE ESOPHAGEAL WALL AFTER THE FIRST PASS, THEN A PERFORATION OCCURRED IN THE FOLDS OF THE EGJ. THERE WAS NEVER ANY RESISTANCE ON THE BALLOON OR SCOPE AT ANY TIME DURING THE PROCEDURE. THE PHYSICIAN BELIEVED THIS WAS A USER ERROR BUT WOULD LIKE THE CLEANING CAP TO BE INSPECTED AS IT SEEMED SHAPER THAN THE USUAL. THE PATIENT HAD A PRE-EXISTING CONDITION OF OBESITY, GASTROESOPHAGEAL REFLUX DISEASE (GERD), AND CHRONIC DIARRHEA. THE PATIENT WAS PREPPED FOR THE PROCEDURE AND WAS UNDER ANESTHESIA. THEY PERFORMED GASTROGAFFIN SWALLOW TWICE TO RULE OUT THE PERFORATION AND THE PERFORATION WAS CLOSED USING CLIPS. THE PATIENT WAS MONITORED OVER WEEKEND, TREATED WITH "IV ABX" AND WAS DISCHARGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    756804 DAR GEI COVIDIEN LP BARRX 64082 F2510189X

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention