BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRACISION HARMONIC SCALPEL HAND PIECE

    MDR report key: 725895 · Received June 7, 2006

    Report

    Report Number
    1527736-2006-02589
    Event Type
    Malfunction
    Date Received
    June 7, 2006
    Date of Event
    June 5, 2006
    Report Date
    June 6, 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
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INFORMATION WAS NOT PROVIDED BY THE CONTACT. INFORMATION US UNAVAILABLE; DEVICE WAS NOT RETURNED FOR EVALUATION. (510(K)#K002906)

    Description of Event or Problem · 1

    DURING A LAP NISSEN PROCEDURE, THE 4-40 STUD BROKE ON THE HAND PIECE. THEY USED ANOTHER HAND PIECE AND COMPLETED THE CASE WITH NO PATIENT CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ULTRACISION HARMONIC SCALPEL HAND PIECE LFL LFL ETHICON ENDO SURGERY, INC.(CINCINNATI) NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN GENERATOR