BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RF ABLATION SYS E SERIES JPN

    MDR report key: 4192356 · Received October 22, 2014

    Report

    Report Number
    1717344-2014-00925
    Event Type
    Malfunction
    Date Received
    October 22, 2014
    Date of Event
    September 22, 2014
    Report Date
    September 24, 2014
    Manufacturer
    COVIDIEN LP
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DATE OF INITIAL REPORT: 10/22/2014. DATE OF FOLLOW-UP REPORT: 01/19/2015. EVALUATION OF THE GENERATOR WAS PERFORMED BY COVIDIEN JAPAN SERVICE CENTER. INVESTIGATION ISOLATED THE FAILURE TO THE INTERNAL HIGH VOLTAGE PCB BUT THE ROOT CAUSE WAS NOT IDENTIFIED. THE HIGH VOLTAGE PCB WAS REPLACED TO ADDRESS THE FAILURE.

    Additional Manufacturer Narrative · 1

    (B)(4). THE RETURN OF THE INCIDENT SAMPLE HAS BEEN REQUESTED. TO DATE, IT HAS NOT BEEN RECEIVED FOR EVALUATION. ADDITIONAL QUESTIONS IN REGARD TO THE INCIDENT HAVE BEEN ASKED. IF THE SAMPLE IS RECEIVED, OR IF ADDITIONAL INFORMATION PERTINENT TO THE INCIDENT IS OBTAINED, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT DURING AN ABLATION PROCEDURE, THE POWER OF THE GENERATOR SHUT OFF UNINTENTIONALLY. THE POWER PLUG WAS RECONNECTED TO THE MAIN BUT THE GENERATOR WOULD NOT POWER ON. THE TARGET LESION WAS NOT ABLATED DUE TO THE ISSUE AND THE PROCEDURE WAS CALLED OFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    673608 RF ABLATION SYS E SERIES JPN RF ABLATION GENERATOR GEI COVIDIEN LP RFAGENJ

    Patients

    Seq Age Sex Outcome Treatment
    1