BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRACISION SURG, DEV, BLADES 5MM OPEN

    MDR report key: 729215 · Received June 16, 2006

    Report

    Report Number
    1527736-2006-02743
    Event Type
    Malfunction
    Date Received
    June 16, 2006
    Date of Event
    June 6, 2006
    Report Date
    June 9, 2006
    Manufacturer
    ETHICON ENDO-SURGERY, INC.
    Product Code
    LFL
    PMA / PMN Number
    k010898
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INFORMATION NOT AVAILABLE, DEVICE NOT RETURNED FOR ANALYSIS. 510K#: K010898.

    Description of Event or Problem · 1

    DURING A POSTNASAL NERVE RESECTION PROCEDURE, THE BLADE BROKE. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. NO PATIENT CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ULTRACISION SURG, DEV, BLADES 5MM OPEN LFL LFL ETHICON ENDO-SURGERY, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN GENERATOR, HANDPIECE