BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ISPAN SULFUR HEXAFLUORIDE (SF6) GAS

    MDR report key: 1950123 · Received December 9, 2010

    Report

    Report Number
    1610287-2010-00150
    Event Type
    Malfunction
    Date Received
    December 9, 2010
    Date of Event
    November 9, 2010
    Report Date
    November 9, 2010
    Manufacturer
    ALCON - FORT WORTH / ALCON LABORATORIES, INC.
    Product Code
    LPO
    PMA / PMN Number
    P900067
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS RETURNED FOR ANALYSIS. THE VALVE HANDLE LABEL HAD BEEN REMOVED AND THE RETAINING SCREW WAS MISSING. THE VALVE WAS FOUND TO BE JAMMED IN THE OPEN POSITION. ONCE LOOSENED, THE VALVE WORKED PROPERLY. THE PRODUCT WAS NOT FOUND TO BE DEFECTIVE. THERE HAVE BEEN NO OTHER COMPLAINTS REPORTED IN THE LOT. THE BATCH RECORD WAS REVIEWED AND SHOWED NO UNUSUAL MFG ISSUES. ADDITIONAL INFO WAS REQUESTED ON 11/10/2010 AND 11/15/2010 BY PHONE AND BY MAIL. (B)(4).

    Description of Event or Problem · 1

    A FACILITY REPORTED THAT THE BLACK CYLINDER KNOB WOULD NOT TURN ON THE INTRAOCULAR GAS TANK UPON FIRST USE, WHICH RESULTED IN A DELAY OF APPROX 1.5 HOURS TO THE RETINOPEXY PROCEDURE. THERE WAS NO BACK-UP TANK AND ANOTHER INTRAOCULAR GAS WAS USED. THERE WAS NO PT IMPACT FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ISPAN SULFUR HEXAFLUORIDE (SF6) GAS INTRAOCULAR GAS LPO ALCON - FORT WORTH / ALCON LABORATORIES, INC. NA 019017

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR