BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HALO360 (115V) GENERATOR

    MDR report key: 2850057 · Received November 26, 2012

    Report

    Report Number
    3004904811-2012-00145
    Event Type
    Injury
    Date Received
    November 26, 2012
    Date of Event
    July 12, 2012
    Report Date
    October 29, 2012
    Manufacturer
    COVIDIEN/BARRX
    Product Code
    GEI
    PMA / PMN Number
    K082202
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THIS IS AN ADVERSE EVENT RECORDED ON A CRF, AS PART OF THE (B)(6). THIS PATIENT WAS PROSPECTIVELY ENROLLED WITH 6 CM LOW GRADE DYSPLASIA. ONE MONTH AFTER PATIENT UNDERWENT A RADIOFREQUENCY ABLATION (RFA) PROCEDURE TO TREAT BARRETT'S ESOPHAGUS, THE PATIENT EXPERIENCED DYSPHAGIA. UPON ENDOSCOPY, A STRICTURE WAS NOTED WHICH WAS SUBSEQUENTLY DILATED. THE PATIENT UNDERWENT ANOTHER DILATION TWO MONTHS LATER AFTER WHICH THE PATIENT'S SYMPTOMS WERE RESOLVED. PER THE PHYSICIAN, THE SEVERITY OF THIS EVENT WAS MILD AND THE RELATIONSHIP OF THE EVENT TO THE DEVICE PROCEDURE WAS PROBABLE. THERE WAS NO DEVICE MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HALO360 (115V) GENERATOR ELECTROSURGICAL COAGULATION SYSTEM GEI COVIDIEN/BARRX NA

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention HALO360+ ABLATION CATHETER: MODEL #31041-22