BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONSTELLATION SURGICAL PROCEDURE PAK

    MDR report key: 6102960 · Received November 15, 2016

    Report

    Report Number
    1644019-2016-01432
    Event Type
    Malfunction
    Date Received
    November 15, 2016
    Date of Event
    October 25, 2016
    Report Date
    January 30, 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
    IN
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE PREVIOUS RECEIVED BY MFR DATE PROVIDED IN THE SUPPLEMENTAL MEDICAL DEVICE REPORT WAS INCORRECT. THE CORRECT DATE WAS 11/16/2016. (B)(4).

    Additional Manufacturer Narrative · 1

    NO SAMPLE HAS BEEN RETURNED FOR EVALUATION FOR THE REPORT OF LEAKING TROCAR; THEREFORE, THE CONDITION OF THE PRODUCT COULD NOT BE VERIFIED. A REVIEW OF THE RELATED DEVICE HISTORY RECORDS FOR THE REPORTED LOT NUMBER INDICATED THAT THE PRODUCT WAS PROCESSED AND RELEASED ACCORDING TO THE PRODUCT¿S ACCEPTANCE CRITERIA. A COMPLAINT HISTORY EXAMINATION INDICATED THERE WAS ONE ADDITIONAL COMPLAINT ASSOCIATED WITH THE LOT FOR THE REPORTED ISSUE. THE ROOT CAUSE FOR THE DEFECT EXPERIENCED BY THE CUSTOMER CANNOT BE DETERMINED. NO ADDITIONAL ACTION IS REQUIRED AT THIS TIME. (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).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    AN OPHTHALMIC SURGEON REPORTED THE VALVE TROCARS WERE FOUND HAVE "NO VALVE SYSTEM" DURING THE PROCEDURE AND LEAKED CONTINUOUSLY. THE PRODUCT SAMPLE WAS RETAINED. THERE WAS NO KNOWN PATIENT HARM. ADDITIONAL INFORMATION WAS REQUESTED; HOWEVER, NONE HAS BEEN RECEIVED TO DATE. NEW INFORMATION: CONFIRMATION OF DATE RECEIVED PENDING: I AM USED INITIAL DATE OF FIRST RECEIPT LISTED. AS IT APPEARS THE COMPANY REPRESENTATIVE MAY HAVE BEEN AWARE OF THE DETAILS AT THAT TIME. THE SURGEON UTILIZED TROCAR PLUGS TO ADDRESS THE VALVED TROCAR LEAKING. THE PROCEDURE WAS COMPLETED DURING THE SAME SESSION AND THERE WAS NO HARM TO THE PATIENT.

    Description of Event or Problem · 1

    AN OPHTHALMIC SURGEON REPORTED THE VALVE TROCARS WERE FOUND TO HAVE "NO VALVE SYSTEM" DURING THE PROCEDURE AND LEAKED CONTINUOUSLY. THE PRODUCT SAMPLE WAS RETAINED. THERE WAS NO KNOWN PATIENT HARM. ADDITIONAL INFORMATION WAS REQUESTED; HOWEVER, NONE HAS BEEN RECEIVED TO DATE.

    Description of Event or Problem · 1

    THE SURGEON UTILIZED TROCAR PLUGS TO ADDRESS THE VALVED TROCAR LEAKING. THE PROCEDURE WAS COMPLETED DURING THE SAME SESSION AND THERE WAS NO HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    755589 CONSTELLATION SURGICAL PROCEDURE PAK GENERAL SURGERY TRAY (KIT) LRO ALCON RESEARCH, LTD. - HOUSTON NA 1866238H

    Patients

    Seq Age Sex Outcome Treatment
    1 Other