BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REVOLUTION DSP 23GA CURVED SCISSORS

    MDR report key: 1592242 · Received January 22, 2010

    Report

    Report Number
    3003398873-2010-00001
    Event Type
    Malfunction
    Date Received
    January 22, 2010
    Date of Event
    December 10, 2009
    Report Date
    December 18, 2009
    Manufacturer
    ALCON GRIESHABER AG
    Product Code
    HNF
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    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

    THE SURGEON REPORTED THAT THE 23GA SCISSORS WERE VERY DIFFICULT TO INSERT THRU 23GA TROCAR PORT. FORCEPS WERE REQUIRED TO HOLD THE TROCAR IN PLACE FOR EACH ENTRY AND EXIT OF SCISSORS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REVOLUTION DSP 23GA CURVED SCISSORS SCISSORS, OPHTHALMIC HNF ALCON GRIESHABER AG 706.52 F64659

    Patients

    Seq Age Sex Outcome Treatment
    1