BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ISPAN SULFUR HEXAFLUORIDE (SF6) GAS

    MDR report key: 2574148 · Received May 9, 2012

    Report

    Report Number
    1610287-2012-00068
    Event Type
    Injury
    Date Received
    May 9, 2012
    Date of Event
    January 6, 2012
    Report Date
    January 17, 2012
    Manufacturer
    ALCON - FORTH WORTH / ALCON LABORATORIES, INC.
    Product Code
    LPO
    PMA / PMN Number
    P900067
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    PHYSICIAN ASSISTANT

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: A REVIEW OF THE COMPLAINT RECORDS SHOWED NO OTHER COMPLAINTS IN THE LOT NUMBER. A REVIEW OF THE BATCH PRODUCTION RECORD SHOWED NO UNUSUAL MFG ISSUES. CYLINDER 33 OF LOT 027310 WAS RETURNED. THE CYLINDER WAS RETURNED W/O THE BLACK VALVE HANDLE. THE VALVE WAS FOUND TO HAVE TOOL MARKS. THE VALVE WAS JAMMED IN THE OPEN POSITION. ONCE LOOSENED, IT COULD BE TURNED BY HAND. ADD'L INFO WAS REQUESTED BY FAX, PHONE AND MAIL ON 01/17/2012, 02/03/2012 AND 04/10/2012. A COMPLETED QUESTIONNAIRE WAS REC'D ON 04/10/2012. (B)(4).

    Description of Event or Problem · 1

    AN OPHTHALMIC ASSISTANT REPORTED THE BLACK KNOB ON THIS PRODUCT WAS STRIPPED AND SPINS FREELY. HE STATED A SURGERY WAS PROLONGED FOR ABOUT ONE HR AS THE STAFF HAD TO BORROW ANOTHER TANK FROM A NEIGHBORING OFFICE. ADD'L INFO WAS REC'D FROM THE OPHTHALMIC ASSISTANT, WHO REPORTED THE PT WAS PREPPED FOR SURGERY WHEN THE EVENT OCCURRED. HE STATED THERE WAS NO IMPACT OR INJURY TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ISPAN SULFUR HEXAFLUORIDE (SF6) GAS INTRAOCULAR GAS LPO ALCON - FORTH WORTH / ALCON LABORATORIES, INC. NA 027310

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR