BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONSTELLATION SURGICAL PROCEDURE PAK

    MDR report key: 6102662 · Received November 15, 2016

    Report

    Report Number
    1644019-2016-01431
    Event Type
    Malfunction
    Date Received
    November 15, 2016
    Date of Event
    November 14, 2016
    Report Date
    February 10, 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
    IT
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE DEVICE HISTORY RECORDS TRACEABLE TO THE REPORTED LOT NUMBER HAS BEEN PERFORMED. THE DEVICE HISTORY RECORD REVIEW INDICATES THAT THE PRODUCT WAS PROCESSED AND RELEASED ACCORDING TO THE PRODUCT¿S ACCEPTANCE CRITERIA. A COMPLAINT HISTORY EXAMINATION INDICATES THERE ARE ELEVEN ADDITIONAL COMPLAINTS ASSOCIATED WITH THE LOT FOR THE REPORTED ISSUE. NO SAMPLE HAS BEEN RETURNED FOR EVALUATION FOR THE REPORT OF LEAKING TROCAR; THEREFORE, THE CONDITION OF THE PRODUCT COULD NOT BE VERIFIED. A PHOTO AND A VIDEO WERE PROVIDED AND HAVE BEEN REVIEWED BY THE INVESTIGATION SITE. THE PHOTO IS CONFIRMS THE PRODUCTS INFORMATION THE VIDEO CONFIRMS THE REPORTED LEAKING TROCAR. NO SAMPLE WAS RETURNED AND THE DEVICE HISTORY RECORD REVIEW OF THE LOT NUMBER PROVIDED INDICATED PRODUCT WAS PROCESSED AND RELEASED ACCORDING TO THE PRODUCT¿S ACCEPTANCE CRITERIA, THEREFORE THE ROOT CAUSE FOR THE DEFECT EXPERIENCED BY THE CUSTOMER CANNOT BE DETERMINED. THE EXACT ROOT CAUSE FOR THIS COMPLAINT IS UNKNOWN. AN INVESTIGATION HAS BEEN COMPLETED AND ACTION IS PRESENTLY BEING IMPLEMENTED TO REDUCE THE FREQUENCY OF COMPLAINTS FOR THIS ISSUE. COMPLAINTS ARE REVIEWED AND MONITORED AT REGULAR INTERVALS TO EVALUATE EFFECTIVENESS OF ACTIONS TAKEN. NO ADDITIONAL ACTION IS REQUIRED AT THIS TIME. 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. (B)(4).

    Description of Event or Problem · 1

    A HEALTHCARE PROFESSIONAL REPORTED THAT THE VALVED TROCARS LEAKED DURING THE PROCEDURE. THE PROCEDURE WAS COMPLETED WITHOUT ANY CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED. THE PRODUCT SAMPLE IS NOT AVAILABLE FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    755739 CONSTELLATION SURGICAL PROCEDURE PAK GENERAL SURGERY TRAY (KIT) LRO ALCON RESEARCH, LTD. - HOUSTON NA 1909560H

    Patients

    Seq Age Sex Outcome Treatment
    1 Other