BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERTICAL MICROSCISSORS, 1.0MM, DISP

    MDR report key: 2073708 · Received April 13, 2011

    Report

    Report Number
    3003398873-2011-00005
    Event Type
    Malfunction
    Date Received
    April 13, 2011
    Date of Event
    March 10, 2011
    Report Date
    March 14, 2011
    Manufacturer
    ALCON GRIESHABER AG
    Product Code
    HQE
    PMA / PMN Number
    K911808
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER RETURNED ONE SAMPLE OF DISPOSABLE VERTICAL MICROSCISSORS. THE TYVEK FOIL OF THE SAMPLE HAS BEEN REMOVED I.E. THE PACKAGE WAS OPENED WHEN THE INSTRUMENT WAS RECEIVED BY THE MANUFACTURER. THE SAMPLE WAS FUNCTIONALLY AND VISUALLY INSPECTED WITH THE AID OF A PHOTOMICROSCOPE AND WITH VARIOUS MAGNIFICATIONS. THE CUSTOMER'S COMPLAINT WAS CONFIRMED. THE BLADES ARE NOT DAMAGED BUT THE SCISSORS DO NOT CUT ON THE WHOLE LENGTH. THE DEVICE HISTORY RECORD FOR TWO POSSIBLE AFFECTED LOTS WAS REVIEWED. NO ABNORMALITIES THAT COULD HAVE CONTRIBUTED TO THIS EVENT WERE FOUND AND THE PRODUCT WAS RELEASED ACCORDING TO THE MANUFACTURER'S ACCEPTANCE CRITERIA. THE ROOT CAUSE FOR THE SCISSORS NOT CUTTING CANNOT BE DETERMINED. (B)(6).

    Description of Event or Problem · 1

    A SURGEON REPORTED THAT THE VERTICAL SCISSORS WOULD NOT CUT THE TISSUE. THE SCISSORS WERE EXCHANGED AND THE CASE WAS COMPLETED. PATIENT IMPACT IS UNKNOWN. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VERTICAL MICROSCISSORS, 1.0MM, DISP INSTRUMENT, VITREOUS ASPIRATION AND CUTTING, AC-POWERED HQE ALCON GRIESHABER AG 701.01 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NI