BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRACISION HARMONIC SCALPEL CURVED SHEARS (LCS) - PISTOL GRIP 36CM - 15MM ACTI

    MDR report key: 1024213 · Received March 27, 2008

    Report

    Report Number
    1527736-2008-01903
    Event Type
    Malfunction
    Date Received
    March 27, 2008
    Date of Event
    March 5, 2008
    Report Date
    March 6, 2008
    Manufacturer
    ETHICON ENDO-SURGERY, INC.
    Product Code
    GEI
    PMA / PMN Number
    K002981
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN LAR PROCEDURE THAT AFTER 5 MINUTES USING, AN ERROR OCCURRED. THE BLADE TIP BROKE. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ULTRACISION HARMONIC SCALPEL CURVED SHEARS (LCS) - PISTOL GRIP 36CM - 15MM ACTI GEI ETHICON ENDO-SURGERY, INC. NA C4F17N

    Patients

    Seq Age Sex Outcome Treatment
    1 GENERATOR| HANDPIECE