BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONSTELLATION WITH LASER

    MDR report key: 1772300 · Received July 23, 2010

    Report

    Report Number
    2028159-2010-01271
    Event Type
    Injury
    Date Received
    July 23, 2010
    Date of Event
    June 24, 2010
    Report Date
    June 25, 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 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 ADD'L REPORTABLE INFO BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    ADVERSE EVENT(S): "DELAYED PROCEDURE" (SURGICAL PROCEDURE, DELAYED). PRODUCT PROBLEM(S): "CASSETTE COULD NOT PRIME" (FAILURE TO PRIME); "FLOW OBSTRUCTION" (OBSTRUCTION WITHIN DEVICE); "TWO SEPARATE MACHINE" (NO CODE AVAILABLE). THE CUSTOMER REPORTED THAT THE CASSETTE COULD NOT PRIME THE FIRST TIME, THEN IT FAILED ON A FLOW OBSTRUCTION CODE 3308. THIS HAPPENED ON TWO SEPARATE MACHINES WITH THE SAME CASSETTE BEFORE SURGERY COMMENCED. THIS CAUSED THE INTENDED SURGERY TO START AN HOUR LATER WHILE THE PT WAS UNDER ANESTHESIA. ADD'L INFO HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONSTELLATION WITH LASER UNIT, PHACOFRAGMENTATION HQC ALCON - IRVINE TECHNOLOGY CENTER CONSTELLATION 963278H

    Patients

    Seq Age Sex Outcome Treatment
    1 Other CONSTELLATION SYSTEM SURGICAL PAK