BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRACISION

    MDR report key: 555012 · Received September 21, 2004

    Report

    Report Number
    555012
    Event Type
    Malfunction
    Date Received
    September 21, 2004
    Date of Event
    August 2, 2004
    Report Date
    September 21, 2004
    Manufacturer
    VANGUARD MEDICAL CONCEPTS, INC.
    Product Code
    LFL
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    DC, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    WHILE USING A REPROCESSED HARMONIC SCALPEL BY VANGUARD, THE OPERATING TIPS OF THE INSTRUMENT BENT RENDERING THE INSTRUMENT INOPERABLE. THIS IS THE SECOND TIME THIS HAS OCCURRED WITH THIS PHYSICIAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ULTRACISION HARMONIC SCALPEL BLADE LFL VANGUARD MEDICAL CONCEPTS, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR