BEUDAMED
    FDA Adverse Event Death Summary report: N

    COOL-TIP RF SYS 100V ENG

    MDR report key: 3082850 · Received April 16, 2013

    Report

    Report Number
    1717344-2013-00283
    Event Type
    Death
    Date Received
    April 16, 2013
    Report Date
    April 11, 2013
    Manufacturer
    COVIDIEN LP
    Product Code
    GEI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). TO DATE, THE INCIDENT SAMPLE HAS NOT BEEN RETURNED 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 THE PT DIED IN THE CASE. NO ADDITIONAL INFORMATION, INCLUDING PT INFORMATION, IS CURRENTLY AVAILABLE. THE INCIDENT DATE IS UNKNOWN. THE CUSTOMER REPORTED THERE WAS NO PROBLEM WITH THE GENERATOR DURING THE CASE. THE SURGEON STATED IT IS NOT THE PRODUCT THAT CAUSED THE INCIDENT THAT RESULTED IN THE DEATH OF PT. THE POLICE CONDUCTED AN INVESTIGATION AT THE SITE AND REMOVED THE CONCERNING PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    163090 COOL-TIP RF SYS 100V ENG RF ABLATION GENERATOR GEI COVIDIEN LP

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Death