BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CENTURION SURGICAL PROCEDURE PAK

    MDR report key: 6099211 · Received November 14, 2016

    Report

    Report Number
    1644019-2016-01429
    Event Type
    Malfunction
    Date Received
    November 14, 2016
    Date of Event
    October 20, 2016
    Report Date
    April 10, 2017
    Manufacturer
    ALCON RESEARCH, LTD. - HOUSTON
    Product Code
    LRO
    PMA / PMN Number
    K880961
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    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

    A DEVICE HISTORY RECORD REVIEW FOR THE REPORTED LOT SHOWS THAT THE ORDER WAS BUILT TO SPECIFICATION. ONE WET, USED FLUIDICS MANAGEMENT SYSTEM WAS RETURNED FOR THIS COMPLAINT. THE SAMPLE WAS VISUALLY INSPECTED AND SURGICAL DEBRIS AND VISCOELASTIC SUBSTANCE WAS FOUND IN THE ASPIRATION LINE. IT WAS ALSO NOTED THAT THE DRAIN BAG WAS DETACHED FROM THE CASSETTE COVER DUE TO SATURATION. THE SURGICAL DEBRIS WAS ATTEMPTED TO BE PURGED FROM THE ASPIRATION LINE; HOWEVER, THE SUBSTANCE WAS TOO SOLID TO PURGE. THE ASPIRATION TUBING WAS CUT ONE INCH FROM THE CASSETTE INSERTION AND THE ASPIRATION LINE WAS REPLACED WITH ONE FROM THE LAB STOCK. THE SAMPLE WAS FUNCTIONALLY TESTED WITH THE LAB STOCK ASPIRATION LINE AND PASSED TESTING. THE ROOT CAUSE OF THE OCCLUDED SURGICAL DEBRIS AND VISCOELASTIC IN THE ASPIRATION LINE IS UNKNOWN. ONE POTENTIAL ROOT CAUSE IS EXCESSIVE USE AS THE SAMPLE WAS RETURNED USED. WHEN THE OCCLUDED ASPIRATION LINE WAS REPLACED WITH ONE FROM THE LAB STOCK, THE SAMPLE MET SPECIFICATIONS. IN FUTURE TESTING, EVEN IF THE TUBING IS OCCLUDED WITH SURGICAL DEBRIS, THE SAMPLE WILL BE FUNCTIONALLY TESTED TO ATTEMPT TO REPLICATE THE CUSTOMER'S COMPLAINT ON THE CONSOLE. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED "A LOT BUBBLES" DURING SURGERY, WHICH "HINDERED THE SURGEON'S VISION.". THE PROCEDURE WAS COMPLETED WITH THE SAME PRODUCT. THERE WAS NO PATIENT HARM. A PRODUCT SAMPLE HAS BEEN REQUESTED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    750781 CENTURION SURGICAL PROCEDURE PAK GENERAL SURGERY TRAY (KIT) LRO ALCON RESEARCH, LTD. - HOUSTON NA 1902187H

    Patients

    Seq Age Sex Outcome Treatment
    1 Other CENTURION VISION SYSTEM