BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONSTELLATION ULTRAVIT PROBE

    MDR report key: 11934125 · Received June 3, 2021

    Report

    Report Number
    1644019-2021-00383
    Event Type
    Malfunction
    Date Received
    June 3, 2021
    Date of Event
    May 31, 2021
    Report Date
    December 14, 2021
    Manufacturer
    ALCON RESEARCH, LLC - HOUSTON
    Product Code
    MLZ
    UDI-DI
    00380657509492
    PMA / PMN Number
    K093305
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ONE OPENED PROBE WAS RECEIVED, WITHOUT TIP PROTECTOR, IN A POUCH. THE SAMPLE WAS VISUALLY INSPECTED AND FOUND TO BE NONCONFORMING WITH ORANGE/BROWN FOREIGN MATERIAL ON PORT FACE. THE SAMPLE WAS THEN FUNCTIONALLY TESTED FOR ACTUATION AND CUT. THE SAMPLE WAS FOUND TO BE CONFORMING FOR CUT AND NONCONFORMING FOR ACTUATION. THE PROBE WAS DISASSEMBLED AND THE COMPONENTS INSPECTED. NO/MINIMAL WEAR OBSERVED ON INNER CUTTER WHEN COMPARED TO THE DEGREE OF WEAR BASED ON CONTINUOUS ACTUATION OF THE PROBE VISUAL STANDARD PHOTOS. WEAR MARKS OBSERVED ALONG THE INNER CUTTER. THE SAMPLE WAS RETESTED FOR ACTUATION WITH THE PROBE DRIVER AND WAS ABLE TO ACTUATE. THE INITIAL ACTUATION TEST FAILED DUE TO AN INTERFERENCE WITHIN THE PROBE AND ONCE THE INTERFERENCE (NEEDLE ASSEMBLY) WAS REMOVED THE PROBE WAS ABLE TO ACTUATE. NEEDLE HOLDER-RETAINER WAS DISASSEMBLED, THE COMPONENTS WERE INSPECTED AND ALL DEEMED CONFORMING. THE COMPLAINT EVALUATION DOES NOT CONFIRM THE PROBE HAD A CUT FAILURE. THE EVALUATION INDICATES THE PROBE HAD AN ACTUATION FAILURE. THE CUT FUNCTIONALITY OF THE PROBE WAS CONFORMING, HOWEVER, THE OBSERVED ACTUATION FAILURE COULD HAVE CAUSED THE PROBE TO NOT CUT AT THE TIME THE REPORTED EVENT WAS OBSERVED. THE EXACT CAUSE OF THE ACTUATION FAILURE CANNOT BE DETERMINED FROM THE EVALUATION PERFORMED. THE REPORTED CUT FAILURE WAS NOT CONFIRMED AND THE EXACT ROOT CAUSE OF THE ACTUATION FAILURE COULD NOT BE DETERMINED, THEREFORE, NO SPECIFIC ACTION WITH REGARD TO THIS COMPLAINT WAS TAKEN BY THE MANUFACTURING SITE. ALL PROBES ARE 100% VISUALLY INSPECTED AND TESTED FOR ACTUATION, ASPIRATION, AND CUT DURING MANUFACTURING. ANY NON-CONFORMANCES FOUND ARE REMOVED FROM THE LOT AND SCRAPPED. COMPLAINTS ARE REVIEWED AND MONITORED AT REGULAR INTERVALS FOR ANY SIGNIFICANT ADVERSE TRENDS. NO ADVERSE TRENDS HAVE BEEN OBSERVED ASSOCIATED WITH THE REPORTED PRODUCT AND EVENT. NO FURTHER ACTIONS ARE REQUIRED. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Additional Manufacturer Narrative · 0

    A SAMPLE WAS NOT RECEIVED AT THE MANUFACTURING SITE FOR EVALUATION; 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. A SAMPLE WAS NOT RECEIVED AT THE MANUFACTURING SITE AND THE DEVICE HISTORY RECORD REVIEW OF THE LOT NUMBER PROVIDED INDICATED THE PRODUCT WAS PROCESSED AND RELEASED ACCORDING TO THE PRODUCT¿S ACCEPTABLE CRITERIA, THEREFORE; THE ROOT CAUSE FOR THE CUSTOMER COMPLAINT ISSUE CANNOT BE DETERMINED. THE EXACT ROOT CAUSE FOR THIS COMPLAINT IS UNKNOWN, THEREFORE, SPECIFIC ACTION WITH REGARDS TO THIS COMPLAINT CANNOT BE TAKEN. ALL PROBES ARE 100% VISUALLY INSPECTED AND TESTED FOR ACTUATION, ASPIRATION, AND CUT DURING MANUFACTURING. COMPLAINTS ARE REVIEWED AND MONITORED AT REGULAR INTERVALS FOR ANY SIGNIFICANT ADVERSE TRENDS. NO ADVERSE TRENDS HAVE BEEN OBSERVED ASSOCIATED WITH THE REPORTED PRODUCT AND EVENT. 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. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Description of Event or Problem · 1

    A NURSE REPORTED THE PROBE WAS NOT CUTTING AND THERE WAS NO PROBLEM WITH THE ASPIRATION DURING A VITRECTOMY PROCEDURE. THE PRODUCT WAS REPLACED WITH ANOTHER ONE AND THE PROCEDURE WAS COMPLETED. THERE WAS NO HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    827666 CONSTELLATION ULTRAVIT PROBE VITRECTOMY, INSTRUMENT CUTTER MLZ ALCON RESEARCH, LLC - HOUSTON NA 2439011H 00380657509492

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown