BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HALOFLEX (115V) GENERATOR

    MDR report key: 3980195 · Received July 2, 2014

    Report

    Report Number
    3004904811-2014-00022
    Event Type
    Malfunction
    Date Received
    July 2, 2014
    Date of Event
    June 10, 2014
    Report Date
    June 10, 2014
    Manufacturer
    COVIDIEN
    Product Code
    GEI
    PMA / PMN Number
    K092487
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE GENERATOR IS ENROUTE TO THE MANUFACTURING FACILITY AT THE TIME OF THIS REPORT. ONCE THE INVESTIGATION/ANALYSIS IS COMPLETE, A FOLLOW UP WILL BE SUBMITTED. (B)(4).

    Description of Event or Problem · 1

    A PATIENT WITH GASTRIC ANTRAL VASCULAR ECTASIA PRESENTED TO THE EMERGENCY ROOM WITH BLEEDING. BARRX RADIOFREQUENCY ABLATION (RFA) WAS TO BE PERFORMED BUT THE RFA GENERATOR WAS NOT ABLE TO BE USED FOR THE PROCEDURE. ARGON PLASMA COAGULATION WAS USED INSTEAD TO TREAT THE PATIENT. NO RFA PRODUCTS WERE USED IN THE PATIENT. THE PATIENT WAS ANESTHETIZED USING MONITORED ANESTHESIA CARE (MAC). THE MANUFACTURER IS REPORTING THIS EVENT OUR OF AN ABUNDANCE OF CAUTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    388767 HALOFLEX (115V) GENERATOR ELECTROSURGICAL COAGULATION SYSTEM GEI COVIDIEN NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other