BEUDAMED
    FDA Adverse Event Other Summary report: N

    CONSTELLATION WITH LASER

    MDR report key: 1912810 · Received November 5, 2010

    Report

    Report Number
    2028159-2010-02143
    Event Type
    Other
    Date Received
    November 5, 2010
    Date of Event
    October 6, 2010
    Report Date
    October 6, 2010
    Manufacturer
    ALCON - IRVINE TECHNOLOGY CENTER
    Product Code
    HQC
    PMA / PMN Number
    K063583
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    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 INFORMATION BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED DURING A CASE, A SYSTEM MESSAGED APPEARED AND THE SYSTEM REQUIRED A REBOOT. ALSO DURING THE SURGERY, AFTER THE SURGEON ATTEMPTED TO ASPIRATE FLUID FROM THE MACULAR ZONE, THERE WAS A REFLUX FAILURE. AT THE END OF THE CASE, THERE WAS A REPORTED FAILURE OF THE SILICONE EXTRACTION SYSTEM WHICH CAUSED THE SURGEON TO PERFORM THE EXTRACTION MANUALLY. ADDITIONAL INFORMATION WAS RECEIVED BY THE SURGEON INDICATING THE PATIENT WAS UNDERGOING SURGERY TO TREAT A RETINAL DETACHMENT SECONDARY TO AN INTRAOCULAR FOREIGN BODY THAT WAS OPERATED ON 5 YEARS AGO. THE RETINAL DETACHMENT WAS SECONDARY TO A MACULAR HOLE (DUE TO THE INTRAOCULAR FOREIGN BODY). DURING THE PROCEDURE, WHEN THE SUBRETINAL FLUID WAS BEING ASPIRATED THROUGH THE MACULAR HOLE, THE EDGE OF THE MACULAR TISSUE GOT CAUGHT IN THE VITREOTOME. THE SURGEON ATTEMPTED TO CONNECT TO THE REFLUX MODE BUT THE SYSTEM SHUT DOWN AND A SYSTEM MESSAGE DISPLAYED. THE FOOT SWITCH HAD TO BE RESET IN ORDER TO BE ABLE TO PERFORM THE FLUX AS THIS FUNCTION WAS NOT ACTIVATED. HOWEVER, THE REFLUX WAS NOT PERFORMED CORRECTLY BECAUSE 100% HAD NOT BEEN SELECTED ON THE SCREEN. THE SURGEON HAD TO HOLD THE VITREOTOME FOR A WHILE UNTIL IT COULD BE REMOVED FROM THE RETINAL TISSUE. AFTERWARDS, THE EYE HAD TO BE LEFT WITHOUT INFUSION IN ORDER TO PURGE THE SYSTEM ONCE IT WAS RESTARTED AGAIN. THE SYSTEM WAS PURGED WITH THE INFUSION SYSTEM CONNECTED TO THE OCULAR GLOBE, BUT THEN ANOTHER ERROR OCCURRED. AT THE END OF THE SURGERY, THE SILICONE ASPIRATION SYSTEM DID NOT WORK AND THE SILICONE HAD TO BE ASPIRATED MANUALLY FROM THE ANTERIOR CHAMBER. ACCORDING TO THE SURGEON, THERE WILL NOT BE VISUAL IMPACTS TO THE PATIENT DUE TO THE EVENT. THE SURGERY AND PATIENT'S ANESTHESIA WERE PROLONGED BY AN HOUR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONSTELLATION WITH LASER UNIT, PHACOFRAGMENTATION HQC ALCON - IRVINE TECHNOLOGY CENTER CONSTELLATION NA

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR Other| R