BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONSTELLATION SURGICAL PROCEDURE PACK

    MDR report key: 16713772 · Received April 11, 2023

    Report

    Report Number
    1644019-2023-00398
    Event Type
    Malfunction
    Date Received
    April 11, 2023
    Date of Event
    March 6, 2023
    Report Date
    July 12, 2023
    Manufacturer
    ALCON RESEARCH, LLC - HOUSTON
    Product Code
    LRO
    UDI-DI
    00380650000958
    PMA / PMN Number
    K880961
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THREE OPENED PROBES WERE RECEIVED WITH TIP PROTECTORS, IN A TRAYS, FOR THE REPORT. PER FOLLOW UP INFORMATION, TWO OF THE SAMPLE WILL BE EVALUATED UNDER QS# (B)(4) AND ONLY SAMPLE # 1 WILL BE EVALUATED UNDER THIS FILE. THE SAMPLE WAS VISUALLY INSPECTED AND FOUND TO BE CONFORMING. THE SAMPLE WAS THEN FUNCTIONALLY TESTED FOR ACTUATION AND CUT AND WAS FOUND TO BE CONFORMING FOR BOTH FUNCTIONAL TESTS. A REVIEW OF THE DEVICE HISTORY RECORD TRACEABLE TO THE LOT NUMBER OBTAINED FROM THE DEVICE¿S RADIOFREQUENCY IDENTIFICATION (RFID) TAG INDICATES THAT THE PRODUCT WAS PROCESSED AND RELEASED ACCORDING TO THE PRODUCT¿S ACCEPTANCE CRITERIA. THE RETURNED SAMPLE WAS FOUND TO BE CONFORMING, THEREFORE AN ACTUATION FAILURE AS DESCRIBED IN THE COMPLAINT WAS NOT CONFIRMED AND A ROOT CAUSE CANNOT BE DETERMINED FOR THE COMPLAINT AS DESCRIBED BY THE CUSTOMER. NO ACTION WAS TAKEN AS THE RETURNED PROBE WAS MANUFACTURED TO SPECIFICATIONS. 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

    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 · 0

    A PHYSICIAN OF ACTUATION FAILURE OF A CUTTER OCCURRED. THE CONDITION OF ASPIRATION WAS UNKNOWN DURING SURGERY. THE SURGERY WAS COMPLETED WITH THE FOURTH PAK BUT, DID NOT REACH TO 20000 CUTS PER MINUTE (CPM) AND, PROCEDURE WAS COMPLETED SOMEHOW. PATIENT HARM WAS NOT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    425221 CONSTELLATION SURGICAL PROCEDURE PACK GENERAL SURGERY TRAY (KIT) LRO ALCON RESEARCH, LLC - HOUSTON NA 14X7YJ 00380650000958

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown CONSTELLATION VISION SYSTEM.