BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COOL-TIP RF SYS 100V ENG

    MDR report key: 2081458 · Received April 12, 2011

    Report

    Report Number
    1717344-2011-00284
    Event Type
    Malfunction
    Date Received
    April 12, 2011
    Date of Event
    March 18, 2011
    Report Date
    March 22, 2011
    Manufacturer
    COVIDIEN LP (VALLEYLAB)
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE INCIDENT GENERATOR HAS BEEN RECEIVED AT THE (B)(4) FOR EVALUATION. WHEN THE GENERATOR EVALUATION IS COMPLETE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT WHEN THE GENERATOR WAS CHECKED BEFORE THE PROCEDURE, IT COMPLETED THE SELF-CHECK WITHOUT A PROBLEM. HOWEVER, ONCE THE GENERATOR WAS TURNED ON FOR THE PROCEDURE, IT DID NOT PASS SELF-CHECK. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT GENERATOR. NO PATIENT INJURY OCCURRED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK