BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONSTELLATION SURGICAL PROCEDURE PAK

    MDR report key: 6187542 · Received December 19, 2016

    Report

    Report Number
    1644019-2016-01551
    Event Type
    Malfunction
    Date Received
    December 19, 2016
    Date of Event
    November 30, 2016
    Report Date
    March 7, 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
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    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 DEVICE HISTORY RECORD TRACEABLE TO THE REPORTED LOT NUMBER INDICATES THAT THE PRODUCT WAS PROCESSED AND RELEASED ACCORDING TO THE PRODUCT¿S ACCEPTANCE CRITERIA. THE ROOT CAUSE FOR THE DEFECT EXPERIENCED BY THE CUSTOMER CANNOT BE DETERMINED. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS (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

    A CUSTOMER REPORTED LEAKAGE FROM THE TROCAR VALVE DURING SURGERY. THE PRODUCT WAS REPLACED AND THE PROCEDURE WAS COMPLETED WITHOUT CONSEQUENCES TO THE PATIENT. THERE IS NO PRODUCT SAMPLE AVAILABLE FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    835617 CONSTELLATION SURGICAL PROCEDURE PAK GENERAL SURGERY TRAY (KIT) LRO ALCON RESEARCH, LTD. - HOUSTON NA 1860607H

    Patients

    Seq Age Sex Outcome Treatment
    1 Other CENTURION VISION SYSTEM| TROCAR VALVE