BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONSTELLATION SURGICAL PROCEDURE PAK

    MDR report key: 6099194 · Received November 14, 2016

    Report

    Report Number
    1644019-2016-01426
    Event Type
    Malfunction
    Date Received
    November 14, 2016
    Date of Event
    September 26, 2016
    Report Date
    February 14, 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
    HU
    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

    THREE OPENED TROCAR CANNULA/HUB ASSEMBLIES WERE RECEIVED FOR EVALUATION. THE RETURNED SAMPLES WERE VISUALLY INSPECTED. ONE SAMPLE WAS FOUND CONFORMING, ONE SAMPLE WAS FOUND NON-CONFORMING WITH AN OPEN VALVE, AND ONE SAMPLE WAS FOUND NON-CONFORMING WITH A TEAR IN THE SEPTUM. A REVIEW OF THE DEVICE HISTORY RECORDS TRACEABLE TO THE REPORTED LOT NUMBER HAS BEEN PERFORMED. THE DEVICE HISTORY RECORD REVIEW INDICATES THAT THE PRODUCT WAS PROCESSED AND RELEASED ACCORDING TO THE PRODUCT¿S ACCEPTANCE CRITERIA. 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. THE POST ASSEMBLY INSPECTION HAS BEEN DISCONTINUED AND AN EFFECTIVENESS CHECK HAS BEEN ESTABLISHED AND WILL BE MONITORED PERIODICALLY. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED LEAKY TROCAR VALVES DURING AN EYE SURGERY. THE PROCEDURE WAS COMPLETED WITHOUT HARM TO THE PATIENT. A PRODUCT SAMPLE WAS REQUESTED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    749643 CONSTELLATION SURGICAL PROCEDURE PAK GENERAL SURGERY TRAY (KIT) LRO ALCON RESEARCH, LTD. - HOUSTON NA 1731929H

    Patients

    Seq Age Sex Outcome Treatment
    1 Other TROCAR VALVE