BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COOL-TIP SINGLE ELEC 15CM X 1CM KIT

    MDR report key: 813468 · Received February 5, 2007

    Report

    Report Number
    1717344-2007-00034
    Event Type
    Injury
    Date Received
    February 5, 2007
    Date of Event
    January 4, 2007
    Report Date
    January 9, 2007
    Manufacturer
    VALLEYLAB QA
    Product Code
    GEI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PROCEDURE: RADIOFREQUENCY ABLATION. REPORTEDLY, THE TIP OF THE DEVICE BROKE OFF WHILE INSIDE THE PT'S (BONE) CAVITY AND STUCK INSIDE BONE. THIS WAS NOTICED AFTER THE NEEDLE WAS REMOVED. THE SURGEON CONTINUED THE PROCEDURE WITH THE SAME DEVICE. "THE NEEDLE WAS IRRETRIEVABLE AND WAS BETTER LEFT INSIDE THE PT." THE BONE TUMOR DID NOT REQUIRE ANY FLUID SO STERILITY WAS NOT AN ISSUE AND A BONE BIOPSY NEEDLE WAS USED FOR THE SURGERY. PT PROGRESS REPORT STATES THAT THE PT HAS NOT REPORTED ANY PAIN AS A RESULT OF THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COOL-TIP SINGLE ELEC 15CM X 1CM KIT ELECTROSURGICAL ACCESSORY GEI VALLEYLAB QA * 105511

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Required Intervention