BEUDAMED
    FDA Adverse Event Other Summary report: N

    N-TRAP STONE ENTRAPMENT AND EXTRACTION DEVICE

    MDR report key: 1067897 · Received June 26, 2008

    Report

    Report Number
    1825146-2008-00025
    Event Type
    Other
    Date Received
    June 26, 2008
    Manufacturer
    COOK UROLOGICAL, INC.
    Product Code
    FFL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A PROPER EVALUATION CANNOT BE PERFORMED DUE TO THE PRODUCT NOT BEING RETURNED FOR EVALUATION. INFORMATION RECEIVED INDICATES THE PHYSICIAN INVOLVED HAS INDICATED TO THE COOK SALES REPRESENTATIVE THIS INCIDENT WAS HIS FAULT; THE LASER WAS TOO CLOSE TO THE BASKET WHEN THE LASER WAS FIRED. THE PHYSICIAN REMOVED THE BASKET PORTION WITHOUT INCIDENT USING 3 PRONG GRASPERS. NO HARM TO THE PATIENT WAS REPORTED. CUSTOMER USE ERROR HAS CAUSED THE CUSTOMER'S DIFFICULTY.

    Description of Event or Problem · 1

    CUSTOMER STATES: "SURGEON BLEW END OFF THE N-TRAP USING A LASER. THE LASER FIBER WAS TOO CLOSE TO THE BASKET AND BLEW IT OFF. SURGEON WENT IN USING 3 PRONG GRASPERS TO REMOVE. NO HARM TO PATIENT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 N-TRAP STONE ENTRAPMENT AND EXTRACTION DEVICE STONE EXTRACTOR FFL COOK UROLOGICAL, INC. NA U1717780

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention