BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERTICAL MICROSCISSORS, 1.0MM, DISP

    MDR report key: 1653615 · Received April 2, 2010

    Report

    Report Number
    3003398873-2010-00004
    Event Type
    Malfunction
    Date Received
    April 2, 2010
    Date of Event
    March 4, 2010
    Report Date
    March 5, 2010
    Manufacturer
    ALCON GRIESHABER AG
    Product Code
    HQE
    PMA / PMN Number
    K911808
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    PRODUCT PROBLEM: DULL SCISSORS. THE SURGEON REPORTED THAT THE SCISSORS WOULD NOT CUT THE TISSUE. NO PATIENT HARM WAS REPORTED. ADDITIONAL FOLLOW-UP 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 F65129

    Patients

    Seq Age Sex Outcome Treatment
    1