BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFINITI VISION SYSTEM, ACCESSORY, FOOTSWITCH

    MDR report key: 4608486 · Received March 17, 2015

    Report

    Report Number
    2028159-2015-05270
    Event Type
    Malfunction
    Date Received
    March 17, 2015
    Report Date
    July 28, 2015
    Manufacturer
    ALCON RESEARCH, LTD. - IRVINE TECHNOLOGY CENTER
    Product Code
    HQC
    PMA / PMN Number
    K120912
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    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).

    Additional Manufacturer Narrative · 1

    THE CUSTOMER CALLED THE COMPANY REPRESENTATIVE TO ASSIST WITH TROUBLESHOOTING. THE CUSTOMER REQUESTED A REPLACEMENT FOOTSWITCH. A REVIEW OF THE CUSTOMER¿S COMPLAINT HISTORY FOR THE LAST 24 MONTHS DID NOT SHOW ANY PREVIOUS COMPLAINTS OF THIS KIND AGAINST THE SYSTEM. THE FOOTSWITCH WAS MANUFACTURED ON AUGUST 8, 2007. THE ASSOCIATED SYSTEM WAS MANUFACTURED ON AUGUST 24, 2010. BASED ON QA ASSESSMENT, THE PRODUCT MET SPECIFICATIONS AT THE TIME OF RELEASE. THE FOOTSWITCH WAS RECEIVED FOR EVALUATION. A VISUAL ASSESSMENT OF THE RETURNED SAMPLE REVEALED SMALL SCRATCHES, FILTH, RUBBER FRAY AND DENTS. THE FOOTSWITCH (WAS CONNECTED TO A CALIBRATED SYSTEM HOTBED AND TESTED. THE REPORTED EVENT WAS REPLICATED, WITH THE SWITCHES BEING FUNCTIONAL BUT THE SYSTEM WOULD NOT RESPOND TO TREADLE ACTION. NO SYSTEM MESSAGE DISPLAYED. THE FOOTSWITCH WAS OPENED TO ISOLATE THE ISSUE AND THE RED WIRE THAT CONNECTS TO THE MICRO SWITCH WAS DISCONNECTED. THE RED WIRE WAS SOLDERED BACK ONTO THE MICRO SWITCH. THE FOOTSWITCH WAS TESTED CONNECTED TO A CALIBRATED SYSTEM HOTBED AND TESTED. NO NONCONFORMITIES OBSERVED. THE ROOT CAUSE OF THE REPORTED EVENT CAN BE ATTRIBUTED TO THE RED WIRE THAT CONNECTS TO THE MICRO SWITCH BEING DISCONNECTED. HOWEVER, IT IS UNKNOWN AS TO HOW THIS RED WIRE BECAME DETACHED. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THAT A FOOTSWITCH WOULD NOT GO OUT OF POSITION 0 BEFORE A PROCEDURE. THERE WAS NO PATIENT INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    182335 INFINITI VISION SYSTEM, ACCESSORY, FOOTSWITCH UNIT, PHACOFRAGMENTATION HQC ALCON RESEARCH, LTD. - IRVINE TECHNOLOGY CENTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other