BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONSTELLATION SURGICAL PROCEDURE PAK

    MDR report key: 6190739 · Received December 20, 2016

    Report

    Report Number
    1644019-2016-01559
    Event Type
    Malfunction
    Date Received
    December 20, 2016
    Report Date
    March 1, 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
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NO SAMPLE HAS BEEN RETURNED FOR EVALUATION; THEREFORE, THE CONDITION OF THE PRODUCT COULD NOT BE VERIFIED. NO LOT NUMBER WAS IDENTIFIED WITH THIS COMPLAINT; THEREFORE, LOT HISTORY AND COMPLAINT HISTORY REVIEWS COULD NOT BE CONDUCTED. 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

    (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. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Description of Event or Problem · 1

    FOLLOW UP INFORMATION WAS RECEIVED FROM THE REPORTER; IT WAS INDICATED THAT THE CASE WAS COMPLETED WITH THE SAME PRODUCT. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED LEAKY TROCAR VALVES DURING SURGERY. ADDITIONAL INFORMATION AND PRODUCT SAMPLE HAVE BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    840644 CONSTELLATION SURGICAL PROCEDURE PAK GENERAL SURGERY TRAY (KIT) LRO ALCON RESEARCH, LTD. - HOUSTON NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Other TROCAR VALVE