BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFINITI

    MDR report key: 3192296 · Received June 18, 2013

    Report

    Report Number
    3192296
    Event Type
    Malfunction
    Date Received
    June 18, 2013
    Date of Event
    June 12, 2013
    Report Date
    June 18, 2013
    Manufacturer
    ALCON RESEARCH, LTD.
    Product Code
    HQC
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US

    Narratives

    Description of Event or Problem · 1

    THREE PATIENTS HAD BEEN SCHEDULED FOR ELECTIVE CATARACT SURGERY. IN PREPARATION FOR SURGERY, SURGEON NOTED THAT THE FOOT PEDAL WAS NOT WORKING, ATTEMPTED SEVERAL TIMES UNSUCCESSFULLY TO FIX PROBLEM. CASES WERE CANCELED EXCEPT FOR ONE PATIENT WHO WAS IN HOUSE AND UNDERWENT CATARACT SURGERY BY ANOTHER PHYSICIAN USING A DIFFERENT PROCEDURE. PER STAFF, IT IS BELIEVED THIS MAY HAVE BEEN A COMPUTER GLITCH THAT CAUSED THE PEDAL TO NOT FUNCTION INITIALLY. EQUIPMENT WAS TAKEN OUT OF SERVICE UNTIL CHECKED OUT. THERE ARE NOW DISPOSABLE SUPPLIES TO USE WITH OTHER MACHINE IF INFINITI IS NOT WORKING. BIOMEDICAL ENGINEER TO FOLLOW UP WITH COMPANY REPRESENTATIVE.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?FOR ALL THREE PATIENTS, DIAGNOSIS WAS NUCLEAR SCLEROSIS AND THEY WERE TO UNDERGO CATARACT SURGERY USING INFINITY.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    277271 INFINITI UNIT, PHACOFRAGMENTATION HQC ALCON RESEARCH, LTD. 210-0000-503 *

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR