BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRACISION SURGERY REUSABLE DEVICES, HANDPIECE 54,55

    MDR report key: 3112166 · Received October 11, 2006

    Report

    Report Number
    1527736-2006-05191
    Event Type
    Malfunction
    Date Received
    October 11, 2006
    Date of Event
    September 14, 2006
    Report Date
    September 18, 2006
    Manufacturer
    ETHICON ENDO-SURGERY, INC. (CINCINNATI)
    Product Code
    LFL
    PMA / PMN Number
    K002906
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFO ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING SET UP FOR A THYROIDECTOMY, THE MOUNTING SCREW BROKE ON THE DEVICE. CASE WAS COMPLETED BY USING A REPLACEMENT. NO PT CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ULTRACISION SURGERY REUSABLE DEVICES, HANDPIECE 54,55 LFL ETHICON ENDO-SURGERY, INC. (CINCINNATI) NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK GENERATOR