BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HALO360 (230V) GENERATOR

    MDR report key: 2932168 · Received January 25, 2013

    Report

    Report Number
    3004904811-2013-00003
    Event Type
    Injury
    Date Received
    January 25, 2013
    Date of Event
    July 3, 2011
    Report Date
    October 21, 2012
    Manufacturer
    COVIDIEN/BARRX
    Product Code
    GEI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT WAS TAKEN FROM OUR CLINICAL REGISTRY. NO SAMPLE WAS RETURNED THEREFORE NO ANALYSIS WAS PERFORMED. SHOULD ADDITIONAL INFORMATION PERTINENT TO THIS EVENT BECOME AVAILABLE, 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). AFTER A FOCAL ABLATION, THE PATIENT EXPERIENCED DYSPHAGIA. AT ONE MONTH FOLLOW UP, A STRICTURE WAS FOUND AT 26 CM. ANOTHER STRICTURE WAS FOUND AT 30-35 CM. THE PATIENT WAS SUBSEQUENTLY DILATED AND PRESCRIBED PROTON PUMP INHIBITORS (PPI) TO BE TAKEN FOR ONE MONTH. IT WAS REPORTED THAT THE SYMPTOMS IMPROVED. AT 3 MONTH FOLLOW UP, THE STRICTURES REMAINED AND THE PATIENT WAS DILATED A SECOND TIME. AT THE FOLLOW UP 8 MONTHS POST PROCEDURE, THERE WERE NO STRICTURES. PER THE PHYSICIAN, THE SEVERITY OF THE EVENT WAS SEVERE, THE RELATIONSHIP OF THE EVENT TO THE DEVICE PROCEDURE WAS PROBABLE AND THERE WAS NO DEVICE MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    36157 HALO360 (230V) GENERATOR ELECTROSURGICAL COAGULATION SYSTEM GEI COVIDIEN/BARRX NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention