BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ISPAN SULFUR HEXAFLUORIDE (SF6) GAS

    MDR report key: 2945248 · Received February 1, 2013

    Report

    Report Number
    1610287-2013-00003
    Event Type
    Malfunction
    Date Received
    February 1, 2013
    Date of Event
    December 31, 2012
    Report Date
    January 3, 2013
    Manufacturer
    ALCON - FORT WORTH / ALCON LABORATORIES INC
    Product Code
    LPO
    PMA / PMN Number
    P900067
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS RETURNED FOR ANALYSIS. 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. THERE WERE NO OTHER COMPLAINTS REPORTED IN THE LOT. (B)(4).

    Description of Event or Problem · 1

    A USER FACILITY REPORTED THAT THE BLACK CYLINDER TANK KNOB WOULD NOT TURN, WHICH RESULTED IN A RESCHEDULED PROCEDURE. ADDITIONAL INFORMATION WAS RECEIVED FROM AN OPHTHALMIC TECH, WHO INDICATED THE EVENT RESOLVED WITH TREATMENT. IN THE SURGEON'S OPINION, THE DEVICE DID NOT CAUSE THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    44470 ISPAN SULFUR HEXAFLUORIDE (SF6) GAS INTRAOCULAR GAS LPO ALCON - FORT WORTH / ALCON LABORATORIES INC NA 104208

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR