BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONSTELLATION SURGICAL PROCEDURE PAK

    MDR report key: 6149726 · Received December 6, 2016

    Report

    Report Number
    1644019-2016-01512
    Event Type
    Malfunction
    Date Received
    December 6, 2016
    Report Date
    February 22, 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
    ND, 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 ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Additional Manufacturer Narrative · 1

    NO SAMPLE WAS RETURNED AND THE DEVICE HISTORY RECORD REVIEW OF THE LOT NUMBER PROVIDED INDICATED PRODUCT WAS RELEASED ACCORDING TO PRODUCT¿S ACCEPTANCE CRITERIA, THEREFORE, THE ROOT CAUSE FOR THE DEFECT EXPERIENCED BY THE CUSTOMER CANNOT BE DETERMINED. ANY NON-CONFORMANCES, SUCH AS DAMAGED TIPS OR CUTTING EDGES, ARE REMOVED FROM THE LOT AND SCRAPPED. COMPLAINTS ARE REVIEWED AND MONITORED AT REGULAR INTERVALS FOR ANY SIGNIFICANT ADVERSE TRENDS. NO ADDITIONAL ACTION IS REQUIRED AT THIS TIME. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED HAVING PROBLEMS WITH DULL TROCARS. NO PATIENT HARM REPORTED. ADDITIONAL INFORMATION AND SAMPLE HAVE BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    797555 CONSTELLATION SURGICAL PROCEDURE PAK GENERAL SURGERY TRAY (KIT) LRO ALCON RESEARCH, LTD. - HOUSTON NA 1926063H

    Patients

    Seq Age Sex Outcome Treatment
    1 Other