BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONSTELLATION SURGICAL PROCEDURE PAK

    MDR report key: 6018832 · Received October 11, 2016

    Report

    Report Number
    1644019-2016-01307
    Event Type
    Malfunction
    Date Received
    October 11, 2016
    Date of Event
    March 23, 2016
    Report Date
    January 3, 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
    MI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: A REVIEW OF THE RELATED DEVICE HISTORY RECORD FOR THE REPORTED LOT NUMBER INDICATES THAT THE PRODUCT WAS PROCESSED AND RELEASED ACCORDING TO THE PRODUCT¿S ACCEPTANCE CRITERIA. A COMPLAINT HISTORY EXAMINATION INDICATES THERE ARE 26 ADDITIONAL COMPLAINTS ASSOCIATED WITH THE LOT FOR THE REPORTED ISSUE. THREE OPENED TROCAR CANNULA/HUB ASSEMBLIES WERE RECEIVED FOR EVALUATION. THE RETURNED SAMPLES WERE VISUALLY INSPECTED. ONE SAMPLE WAS FOUND CONFORMING AND TWO SAMPLES WERE FOUND NON-CONFORMING WITH OPEN VALVES. THE CONFORMING TROCAR WAS THEN FUNCTIONALLY TESTED FOR LEAKING AND WAS FOUND CONFORMING. THE RETURNED SAMPLES INCLUDED OPEN VALVES. THIS COMPLAINT EVALUATION WAS NOT ABLE TO DETERMINE THE ROOT CAUSE OF THE IDENTIFIED VALVE CONDITIONS. POSSIBLE ROOT CAUSES FOR THE NONCONFORMING CONDITIONS INCLUDE VALVE MANUFACTURING CONTROLS, VALVE HANDLING DURING ASSEMBLY AND HANDLING IN USE. THE EXACT ROOT CAUSE FOR THIS COMPLAINT IS UNKNOWN. AN INVESTIGATION HAS BEEN OPENED IN ORDER TO IMPROVE PERFORMANCE OF THE VALVES. COMPLAINTS ARE REVIEWED AND MONITORED AT REGULAR INTERVALS TO EVALUATE EFFECTIVENESS OF ACTIONS TAKEN. NO ADDITIONAL ACTION IS REQUIRED AT THIS TIME. (B)(4).

    Additional Manufacturer Narrative · 1

    A PRODUCT SAMPLE WAS RECEIVED AND IT IS AWAITING EVALUATION. 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

    A CLINICAL ENGINEER INTERN REPORTED THAT ONE TROCAR LEAKED DURING A RIGHT EYE VITREORETINAL PROCEDURE. THE PROCEDURE WAS COMPLETED WITH NO CONSEQUENCES OR IMPACT TO THE PATIENT INVOLVED. THE PRODUCT SAMPLE HAS BEEN REQUESTED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    670310 CONSTELLATION SURGICAL PROCEDURE PAK GENERAL SURGERY TRAY (KIT) LRO ALCON RESEARCH, LTD. - HOUSTON NA 1817608H

    Patients

    Seq Age Sex Outcome Treatment
    1 Other