BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HALO90 GENERATOR

    MDR report key: 3121772 · Received May 10, 2013

    Report

    Report Number
    3004904811-2013-00022
    Event Type
    Injury
    Date Received
    May 10, 2013
    Date of Event
    February 2, 2012
    Report Date
    April 12, 2013
    Manufacturer
    COVIDIEN
    Product Code
    GEI
    PMA / PMN Number
    K062723
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE SITE DID NOT RETURN ANY DEVICE, THEREFORE, NO DEVICE EVALUATION WAS PERFORMED. IF ADDITIONAL INFORMATION PERTINENT TO THIS EVENT IS OBTAINED, A FOLLOW-UP REPORT WILL BE SUBMITTED. COVIDIEN REFERENCE # (B)(4).

    Description of Event or Problem · 1

    THIS IS AN ADVERSE EVENT RECORDED ON A CASE REPORT FORM (CRF) AS PART OF THE (B)(6) PATIENT REGISTRY. THIS PATIENT WAS PROSPECTIVELY ENROLLED WITH 6CM HIGH GRADE DYSPLASIA. THE PATIENT HAD UNDERGONE MULTIPLE ESOPHAGEAL TREATMENTS INCLUDING TWO ENDOSCOPIC RESECTIONS (ER) AND FIVE RADIOFREQUENCY ABLATION (RFA) PROCEDURES DURING THE PERIOD FROM (B)(6) 2009 - (B)(6) 2010. IN (B)(6) 2012, APPROXIMATELY 2 YEARS AFTER THE LAST RFA, THE PATIENT DEVELOPED SYMPTOMS OF ESOPHAGEAL OBSTRUCTION. A STRICTURE WAS FOUND 34CM FROM THE INCISORS. MULTIPLE PIECES OF UNCHEWED FOOD WERE FOUND IN THE PATIENT'S ESOPHAGUS. THE PATIENT WAS DILATED USING A 57 FR BOUGIE DILATOR. THE PHYSICIAN ATTEMPTED TO PUSH THE FOOD THROUGH THE STRICTURE WITH THE SCOPE BUT WAS UNSUCCESSFUL. THE FOOD WAS REMOVED USING A ROTH NET. ONCE COMPLETE, THE SCOPE PASSED EASILY THROUGH THE GE JUNCTION. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    207295 HALO90 GENERATOR ELECTROSURGICAL COAGULATION SYSTEM GEI COVIDIEN NA

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention