BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONSTELLATION SURGICAL PROCEDURE PAK

    MDR report key: 6041188 · Received October 19, 2016

    Report

    Report Number
    1644019-2016-01328
    Event Type
    Malfunction
    Date Received
    October 19, 2016
    Date of Event
    September 27, 2016
    Report Date
    February 14, 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
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A PRODUCT SAMPLE HAS BEEN RECEIVED AT THE MANUFACTURING SITE AND IT IS AWAITING EVALUATION. (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

    ADDITIONAL INFORMATION IN DEVICE EVALUATED BY MFR?, EVALUATION CODES, AND ADDITIONAL MFR NARRATIVE. FIFTEEN UNOPENED TROCAR ASSEMBLIES WERE RECEIVED IN PLASTIC TRAYS FOR THE REPORT OF LEAKING TROCARS. THE RETURNED SAMPLES WERE VISUALLY INSPECTED. FIVE SAMPLES WERE FOUND CONFORMING AND TEN SAMPLES WERE FOUND NON-CONFORMING WITH OPEN VALVES. THE CONFORMING SAMPLES WERE THEN LEAK TESTED AND WERE FOUND CONFORMING. 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. THE VISUAL EXAMINATION OF THE RETURNED SAMPLES IDENTIFIED AN OPEN VALVE CONDITION. THE EVALUATION OF THE SAMPLES COULD NOT DETERMINE THE CAUSE FOR THE VALVE CONDITION. THE EXACT ROOT CAUSE FOR THIS COMPLAINT IS UNKNOWN. AN INTERNAL INVESTIGATION HAS BEEN OPENED TO ADDRESS REPORTS OF A SIMILAR NATURE. (B)(4).

    Description of Event or Problem · 1

    FOLLOW UP INFORMATION WAS RECEIVED FROM THE CUSTOMER. THE PROCEDURE WAS COMPLETED USING THE SAME PRODUCT. THERE WAS NO HARM TO THE PATIENT.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED A LEAKING TROCAR VALVE DURING SURGERY. ADDITIONAL INFORMATION AND PRODUCT SAMPLE HAVE BEEN REQUESTED FOR EVALUATION. NO ADDITIONAL UPDATES HAVE BEEN RECEIVED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    691385 CONSTELLATION SURGICAL PROCEDURE PAK GENERAL SURGERY TRAY (KIT) LRO ALCON RESEARCH, LTD. - HOUSTON NA 1899246H

    Patients

    Seq Age Sex Outcome Treatment
    1 Other TROCAR VALVE