BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONSTELLATION SURGICAL PROCEDURE PAK

    MDR report key: 6131745 · Received November 29, 2016

    Report

    Report Number
    1644019-2016-01463
    Event Type
    Malfunction
    Date Received
    November 29, 2016
    Date of Event
    October 18, 2016
    Report Date
    January 31, 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
    UK
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    NO LOT NUMBER WAS IDENTIFIED WITH THIS COMPLAINT; THEREFORE, LOT HISTORY AND COMPLAINT HISTORY REVIEWS COULD NOT BE CONDUCTED. NO SAMPLE HAS BEEN RETURNED FOR EVALUATION; THEREFORE, THE CONDITION OF THE PRODUCT COULD NOT BE VERIFIED. DUE TO AN OBSERVED INCREASED TREND FOR THIS EVENT, AN INTERNAL INVESTIGATION WAS INITIATED TO DETERMINE IF CORRECTIVE AND PREVENTATIVE ACTIONS WERE NECESSARY. A ROOT CAUSE FOR THE INCREASED COMPLAINT RATE WAS FOUND TO BE RELATED TO A MANUFACTURING POST ASSEMBLY INSPECTION PRACTICE. THIS COMPLAINT DOES NOT IDENTIFY A REPORTED LOT AND NO SAMPLE WAS RETURNED FOR EVALUATION SO IT CANNOT BE DETERMINED IF THE COMPLAINT CAN BE ATTRIBUTED TO THE POST ASSEMBLY INSPECTION. THE POST ASSEMBLY INSPECTION HAS BEEN DISCONTINUED AND AN EFFECTIVENESS CHECK HAS BEEN ESTABLISHED AND WILL BE MONITORED PERIODICALLY. (B)(4).

    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).

    Description of Event or Problem · 1

    A NURSE REPORTED THAT THE VALVED TROCARS WERE LEAKING. NO FURTHER PATIENT OR PROCEDURE DETAILS WERE PROVIDED WITH THE INITIAL REPORT. A PRODUCT SAMPLE HAS BEEN REQUESTED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    784154 CONSTELLATION SURGICAL PROCEDURE PAK GENERAL SURGERY TRAY (KIT) LRO ALCON RESEARCH, LTD. - HOUSTON NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Other