BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HARMONIC SCALPEL CURVED SHEAR

    MDR report key: 746188 · Received November 8, 2005

    Report

    Report Number
    1527736-2005-05345
    Event Type
    Malfunction
    Date Received
    November 8, 2005
    Report Date
    October 20, 2005
    Manufacturer
    ETHICON ENDO SURGERY, INC. (CINCINNATI)
    Product Code
    LFL
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    H4, 6: INFO ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    DURING AN LSO PROCEDURE, THE ACTIVE BLADE TIP BROKE OFF IN THE PT. IT WAS RETRIEVED WITHOUT OPENING THE PT. THERE WAS NO PT CONSEQUENCES. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE OF THE SAME PRODUCT CODE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HARMONIC SCALPEL CURVED SHEAR ULTRACISION SURG DEV, CURVED SHEARS, ENDO LFL ETHICON ENDO SURGERY, INC. (CINCINNATI) NA Y45F5X

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN GENERATOR| HANDPIECE