BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HALOFLEX (115V) GENERATOR

    MDR report key: 3161804 · Received June 6, 2013

    Report

    Report Number
    3004904811-2013-00026
    Event Type
    Injury
    Date Received
    June 6, 2013
    Date of Event
    May 29, 2013
    Report Date
    May 29, 2013
    Manufacturer
    COVIDIEN
    Product Code
    GEI
    PMA / PMN Number
    K092487
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE SITE DID NOT RETURN ANY DEVICE THEREFORE NO DEVICE EVAL WAS PERFORMED. A REVIEW OF THE DEVICE HISTORY RECORDS FOUND NO ISSUES. IF ADDITIONAL INFO PERTINENT TO THIS EVENT IS OBTAINED, A F/U REPORT WILL BE SUBMITTED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PT WITH 7 CM OF NON-DYSPLASTIC BARRETT'S ESOPHAGUS WITH A HISTORY OF PRIOR DILATION OF THE ESOPHAGUS UNDERWENT A CIRCUMFERENTIAL ABLATION OF THE ENTIRE SEGMENT. THE PROCEDURE PROGRESSED NORMALLY WITHOUT SIGNIFICANT BLEEDING OR OTHER ABNORMALITIES. TWO DAYS POST PROCEDURE, THE PT COMPLAINED OF DYSPHAGIA. A BARIUM SWALLOW REVEALED A "RATTY" APPEARANCE OF THE ESOPHAGUS WITH A FOCAL 70% NARROWING. THE TREATING PHYSICIAN DECIDED TO WAIT SIX WEEKS BEFORE PERFORMING A F/U ENDOSCOPY. THE F/U ENDOSCOPY ON (B)(6) 2013 REVEALED A WEB AT THE GASTROESOPHAGEAL JUNCTION WITH STENOSIS, PREVENTING PASSAGE OF THE SCOPE. THE TREATING PHYSICIAN DILATED THE PT'S ESOPHAGUS TO 13 MM. NO FURTHER INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    251673 HALOFLEX (115V) GENERATOR ELECTROSURGICAL COAGULATION SYSTEM GEI COVIDIEN NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention