BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SULFA HEXAFLUORIDE (SF6)

    MDR report key: 1041333 · Received April 7, 2008

    Report

    Report Number
    1041333
    Event Type
    Injury
    Date Received
    April 7, 2008
    Date of Event
    February 18, 2008
    Report Date
    April 7, 2008
    Manufacturer
    ALCON LABORATORIES, INC.
    Product Code
    LPO
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    KY, US

    Narratives

    Description of Event or Problem · 1

    SURGEON PERFORMED THE FOLLOWING SURGERY DUE TO RETINA DETACHMENT: SCLERAL BUCKLE (240, 0250, 276 ELEMENTS), EXTERNAL DRAINS FOR SUBRETINAL FLUID, PARS PLANA VITRECTOMY, FLUID AIR EXCHANGE, ENDOLASER PHOTOCONGULATION AND INJECTION OF 30% SF6 GAS ON RIGHT EYE. THE PT PRESENTED TO SURGEON OFFICE FOR FOLLOW UP AND WAS NOTED TO HAVE A COMPLETE DETACHMENT OF THE RIGHT EYE AGAIN. A 2ND SURGERY WAS PERFORMED ON 10 DAYS LATER BY DIFFERENT PHYSICIAN. THIS PROCEDURE WAS: RIGHT PARS PLANA VITRECTOMY, AIR FLUID EXCHANGE, ENDO LASER, AND INJECTION OF 14% C3F8 GAS. OPERATIVE REPORT STATES THERE WAS 10% GAS LEFT OF THE PREVIOUSLY PLACED GAS (FROM ORIGINAL PROCEDURE) WHEN THE 2ND SURGERY WAS STARTED. SURGEON HAS INDICATED THE SF6 GAS BUBBLE FROM ORIGINAL PROCEDURE DISSIPATED FASTER THAN IT SHOULD HAVE. THE BUBBLE IS NEEDED TO TAMPONADE THE DETACHMENT. WHEN GAS WAS DELIVERED TO SURGICAL FIELD, ROUTINE PROCESS WAS FOLLOWED. THE TANK GAUGE INDICATED IT HAD PRESSURE, THE SYRINGE PLUNGER RETRACTED AS GAS FROM THE TANK WAS DISPENSED INTO THE SYRINGE. THE SYRINGE WAS PURGED 2-3 TIMES AND THE LAST SYRINGE WAS KEPT ON THE FIELD HOLDING PURE SF6 GAS. THE SURGEON THEN MIXED THE PERCENTAGE HE WANTED TO PUT IN THE EYE.====================== MANUFACTURER RESPONSE FOR OPHTHALMIC GAS, SULFA HEXAFLUORIDE (SF6)======================THEY WANT THE TANK RETURNED TO THEM FOR EVALUATION. WAITING FOR INSTRUCTIONS FROM ALCON TO RETURN GAS TANK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SULFA HEXAFLUORIDE (SF6) OPHTHALMIC GAS, SF6 LPO ALCON LABORATORIES, INC. * 623308
    2 VICTOR REGULATOR, COMPRESSED GAS CAN VICTOR MEDICAL PRODUCTS LB150A180 *

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Other| R