BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRACISION SURGERY REUSABLE DEVICES, HANDPIECE 54, 55

    MDR report key: 726641 · Received June 15, 2006

    Report

    Report Number
    1527736-2006-02721
    Event Type
    Malfunction
    Date Received
    June 15, 2006
    Date of Event
    May 22, 2006
    Report Date
    May 24, 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
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INFORMATION NOT AVAILABLE, DEVICE NOT RETURNED FOR ANALYSIS. (510)(K)#K002906)

    Description of Event or Problem · 1

    THE THREADED STUD BROKE ON HANDPIECE. NO OTHER PROCEDURE INFORMATION AVAILABLE. NO PATIENT CONSEQUENCE REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN