BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONSTELLATION SURGICAL PROCEDURE PAK

    MDR report key: 4863831 · Received June 23, 2015

    Report

    Report Number
    1644019-2015-00605
    Event Type
    Malfunction
    Date Received
    June 23, 2015
    Date of Event
    May 28, 2015
    Report Date
    November 4, 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
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A DEVICE HISTORY RECORD REVIEW FOR EACH OF THE TROCAR LOTS WAS CONDUCTED. ACCORDING TO THE DEVICE HISTORY RECORD REVIEWS, ONE LOT WAS REPROCESSED FOR AN ANOMALY (SEPTUM DAMAGE) THAT COULD HAVE CONTRIBUTED TO THE CUSTOMER COMPLAINT. THE DEVICE HISTORY RECORD REVIEWS DO NOT POINT TO A ROOT CAUSE BECAUSE THE LOT WAS REPROCESSED AND THE PRODUCT RELEASED PER MANUFACTURE¿S ACCEPTANCE CRITERIA. A COMPLAINT HISTORY EXAMINATION INDICATED THIS WAS THE FIFTEENTH COMPLAINT RECEIVED AGAINST THE COMPONENTS OF THE REPORTED FINAL LOT. THE RETURNED SAMPLES WERE VISUALLY INSPECTED AND FOUR OF THE SIX SAMPLES WERE FOUND TO BE CONFORMING. THE TWO NONCONFORMING SAMPLES WERE FOUND TO HAVE A DAMAGED SEPTUM. THE ROOT CAUSE ON HOW THE TWO SAMPLES BECAME DAMAGED IS UNKNOWN. DUE TO AN OBSERVED INCREASED TREND FOR THIS EVENT, AN INTERNAL INVESTIGATION WAS INITIATED TO DETERMINE IF CORRECTIVE AND PREVENTATIVE ACTIONS WERE NECESSARY. A ROOT CAUSE FOR THE INCREASED COMPLAINT RATE WAS FOUND TO BE RELATED TO A MANUFACTURING POST ASSEMBLY INSPECTION PRACTICE. THE POST ASSEMBLY INSPECTION HAS BEEN DISCONTINUED AND AN EFFECTIVENESS CHECK HAS BEEN ESTABLISHED AND WILL BE MONITORED PERIODICALLY. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    A PRODUCT SAMPLE WAS RECEIVED AT THE MANUFACTURING SITE 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. (B)(4).

    Description of Event or Problem · 1

    AN OPHTHALMIC SURGEON REPORTED THAT THE TROCAR CANNULA VALVE LEAKED DURING A VITRECTOMY PROCEDURE. THE SURGERY WAS COMPLETED WITHOUT HARM TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    407353 CONSTELLATION SURGICAL PROCEDURE PAK GENERAL SURGERY TRAY (KIT) LRO ALCON RESEARCH, LTD. - HOUSTON NA 1734482H

    Patients

    Seq Age Sex Outcome Treatment
    1 Other