BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONSTELLATION SURGICAL PROCEDURE PAK

    MDR report key: 4844188 · Received June 15, 2015

    Report

    Report Number
    1644019-2015-00584
    Event Type
    Malfunction
    Date Received
    June 15, 2015
    Date of Event
    May 18, 2015
    Report Date
    September 28, 2015
    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
    TX, US
    Reporter Occupation
    OTHER

    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

    ADDITIONAL INFORMATION: A PRODUCT SAMPLE WAS NOT RETURNED FOR EVALUATION; THEREFORE, THE CONDITION OF THE PRODUCT COULD NOT BE VERIFIED. THE FINAL CUSTOMER'S LOT WAS IDENTIFIED AND DEVICE HISTORY RECORD REVIEW SHOWS THAT THE PRODUCT WAS RELEASED ACCORDING TO THE MANUFACTURER'S ACCEPTANCE CRITERIA. THE ROOT CAUSE FOR THE DEFECT EXPERIENCED BY THE CUSTOMER CANNOT BE DETERMINED. AN INTERNAL INVESTIGATION HAS BEEN OPENED TO ADDRESS REPORTS OF A SIMILAR NATURE. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THAT THE TROCAR VALVES LEAKED DURING THREE SEPARATE VITREORETINAL PROCEDURES. THERE WAS NO PATIENT HARM. THERE ARE NO ADDITIONAL EVENT DETAILS AVAILABLE. PRODUCT SAMPLES WERE REQUESTED FOR EVALUATION. THIS IS THE FIRST PRODUCT REPORT OUT THREE PRODUCT REPORTS RECEIVED FROM THE CUSTOMER.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THAT THE TROCAR VALVES LEAKED DURING THREE SEPARATE VITREORETINAL PROCEDURES. THERE WAS NO PATIENT HARM. THERE ARE NO ADDITIONAL EVENT DETAILS AVAILABLE. PRODUCT SAMPLES WERE REQUESTED FOR EVALUATION. THIS IS THE SECOND PRODUCT REPORT OUT THREE PRODUCT REPORTS RECEIVED FROM THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    388142 CONSTELLATION SURGICAL PROCEDURE PAK GENERAL SURGERY TRAY (KIT) LRO ALCON RESEARCH, LTD. - HOUSTON NA 1726109H

    Patients

    Seq Age Sex Outcome Treatment
    1 Other