BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ISPAN SULFUR HEXAFLUORIDE (SF6) GAS

    MDR report key: 2093503 · Received April 6, 2011

    Report

    Report Number
    1610287-2011-00038
    Event Type
    Malfunction
    Date Received
    April 6, 2011
    Date of Event
    March 4, 2011
    Report Date
    March 7, 2011
    Manufacturer
    ALCON CORP ADMINISTRATION
    Product Code
    LPO
    PMA / PMN Number
    P900067
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE COMPLAINT DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EVALUATION. REVIEW OF (B)(4) WAS COMPLETED AND NO OTHER COMPLAINTS WERE REPORTED FOR THIS LOT. CYLINDER 8 OF LOT 922915 WAS RECEIVED AND THE VALVE COULD NOT BE TURNED BY HAND. THE VALVE WAS FOUND JAMMED IN THE OPEN POSITION. ONCE LOOSENED, THE VALVE COULD BE TURNED BY HAND. NO ROOT CAUSE COULD BE DETERMINED. ADDITIONAL INFORMATION WAS REQUESTED VIA MAIL ON 03/07/2011; VIA PHONE ON 03/24/2011. (B)(4).

    Description of Event or Problem · 1

    A TECHNICIAN REPORTED, THE BLACK KNOB ON THE FACILITY'S TANK WAS FROZEN AND COULD NOT BE LOOSENED DURING A PNEUMATIC RETINOPEXY PROCEDURE. THE SURGEON SWITCHED TO A NEW TYPE OF GAS TANK AND PROCEEDED WITH THE PATIENT'S PROCEDURE. SHE NOTED THERE WAS APPROXIMATELY A 15-20 MINUTE DELAY IN THE SURGERY WITH NO HARM TO THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ISPAN SULFUR HEXAFLUORIDE (SF6) GAS INTRAOCULAR GAS LPO ALCON CORP ADMINISTRATION NA 922915

    Patients

    Seq Age Sex Outcome Treatment
    1