BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ISPAN PERFLUOROPROPANE (C3F8) GAS

    MDR report key: 2972471 · Received February 15, 2013

    Report

    Report Number
    1610287-2013-00005
    Event Type
    Malfunction
    Date Received
    February 15, 2013
    Date of Event
    January 15, 2013
    Report Date
    January 16, 2013
    Manufacturer
    ALCON - FORT WORTH / ALCON LABS, INC.
    Product Code
    LPO
    PMA / PMN Number
    P900066
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    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 INFO BECOMES AVAILABLE. THERE HAVE BEEN NO OTHER SIMILAR COMPLAINTS REPORTED IN THE LOT NUMBER. ADDITIONAL INFO WAS REQUESTED ON (B)(4) 2013 BY PHONE, EMAIL, AND MAIL. A COMPLETED QUESTIONNAIRE HAS NOT BEEN RECEIVED. (B)(4).

    Description of Event or Problem · 1

    A TECH REPORTED THAT THE BLACK KNOB ON THE GAS TANK VALVE THE STAFF HAD BEEN USING SUDDENLY WOULD NOT TURN. WHEN THE STAFF OBTAINED THE BACK UP TANK AND REMOVED THE SEAL, IT WAS NOTED UPON FIRST ATTACHMENT TO THE REGULAR THAT THE BLACK KNOB WAS STUCK ON THAT TANK AS WELL. THE TECH INDICATED THE PT'S PROCEDURE PROCEEDED WITH AN ALTERNATE GAS USED. HE WAS UNAWARE OF ANY COMPLICATIONS AS A RESULT OF THIS CHANGE. ADDITIONAL INFO HAS BEEN REQUESTED. THESE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS EVENT. THIS REPORT IS FOR THE SECOND TANK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    69538 ISPAN PERFLUOROPROPANE (C3F8) GAS INTRAOCULAR GAS LPO ALCON - FORT WORTH / ALCON LABS, INC. NA 130611

    Patients

    Seq Age Sex Outcome Treatment
    1