BEUDAMED
    FDA Adverse Event Other Summary report: N

    LEGACY 20000

    MDR report key: 562138 · Received November 10, 2004

    Report

    Report Number
    562138
    Event Type
    Other
    Date Received
    November 10, 2004
    Date of Event
    November 3, 2004
    Report Date
    November 10, 2004
    Manufacturer
    ALCON LABORATORIES, INC.
    Product Code
    HNN
    Report Source
    User Facility report
    Reporter Location
    KY, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING AN ANTERIOR VITRECTOMY, THE MD STATED THE HAND PIECE MADE A LOUD SWOOSH SOUND AND INJECTED AIR INTO THE EYE. NO PATIENT INJURY. POTENTIAL PATIENT INJURY IF OCCURED DURING A DIFFERENT PART OF THE SURGERY. EQUIPMENT INVOLVED INCLUDED MACHINE AND STERILE HAND PIECE WITH TUBING. HAND PIECE AND TUBING CHANGED OUT AFTER EVENT AND SURGERY CONTINUED. HAND PIECE HAS SEVERAL CONNECTIONS. THE MULTIPLE CONNECTIONS CAN CONTRIBUTE TO HUMAN FACTORS ISSUES AND/OR AN AIR LEAK DUE TO AN UNSECURE CONNECTION. A DESIGN OF LESS CONNECTIONS WOULD REDUCE THE RISK OF POSSIBLE AIR INFILTRATION. THIS WAS ENTERED FOR TRACKING MEANS AND POTENTIAL FOR PATIENT HARM EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LEGACY 20000 CATARACT EQUIPMENT HNN ALCON LABORATORIES, INC. 20000 *
    2 ADVANCED TECH IRRIGATOR GBX ADVANCED TECH * *
    3 * PROBE HXB ACUTONE REF 1006 448255H/ 2004-09

    Patients

    Seq Age Sex Outcome Treatment
    1 3 MO