BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COOL-TIP RF SYS 100V ENG

    MDR report key: 1890754 · Received November 1, 2010

    Report

    Report Number
    1717344-2010-00737
    Event Type
    Malfunction
    Date Received
    November 1, 2010
    Date of Event
    October 4, 2010
    Report Date
    October 6, 2010
    Manufacturer
    COVIDIEN LP (VALLEYLAB)
    Product Code
    GXD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE INCIDENT DEVICE HAS BEEN REC'D AT TYCO HEALTHCARE (B)(4) SERVICE CENTER AND IS UNDER EVAL. WHEN THE DEVICE EVAL IS COMPLETE, A F/U REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT DURING PRE-OPERATION CHECK WITH AN ACT1530 NEEDLE CONNECTED, LL WAS DISPLAYED. THE NEEDLE WAS REPLACED, BUT THE PROBLEM WAS NOT FIXED. THE GENERATOR WAS REPLACED WITH ANOTHER, AND THE ISSUE WAS FIXED. THE PROCEDURE WAS COMPLETED W/O PT HARM.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK ACT1530 NEEDLE ELECTRODE (LOT# UNKNOWN)