BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNSPECIFIED SYSTEM

    MDR report key: 3042900 · Received April 4, 2013

    Report

    Report Number
    2028159-2013-00608
    Event Type
    Malfunction
    Date Received
    April 4, 2013
    Date of Event
    March 6, 2013
    Report Date
    March 6, 2013
    Manufacturer
    ALCON - IRVINE TECHNOLOGY CENTER
    Product Code
    HQC
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    NURSE

    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 ADD'L REPORTABLE INFO BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    A NURSE REPORTED THAT DURING A SPINAL PROCEDURE, THE MICROSCOPE WOULD NOT FOCUS CORRECTLY. AN ALTERNATE MICROSCOPE WAS USED TO COMPLETE THE CASE FOLLOWING A 10 MINUTE DELAY. THERE WAS NO HARM TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    138523 UNSPECIFIED SYSTEM UNSPECIFIED SYSTEM HQC ALCON - IRVINE TECHNOLOGY CENTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 COMBOSCOPE ENDURE USCOPE