BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CENTURION SURGICAL PROCEDURE PAK

    MDR report key: 18300031 · Received December 11, 2023

    Report

    Report Number
    2523835-2023-00694
    Event Type
    Malfunction
    Date Received
    December 11, 2023
    Date of Event
    November 7, 2023
    Report Date
    May 23, 2024
    Manufacturer
    ALCON RESEARCH, LLC - HOUSTON
    Product Code
    LRO
    UDI-DI
    00380657522002
    PMA / PMN Number
    K880961
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION PROVIDED IN D.1., D.3., G.9., H.2., AND H.10. PRODUCT MANUFACTURING SITE UPDATED DUE TO RECEIPT OF CORRECTED PRODUCT INFORMATION (PHACO TIP TO PROCEDURE PAK). MANUFACTURER REPORT NUMBER CORRECTED AND REPORTED UNDER MDR# 2506601 FOR MANUFACTURER REPORT NUMBER 1644019-2024-01086. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Additional Manufacturer Narrative · 0

    ONE OPENED PHACOEMULSIFICATION (PHACO) TIP WITHOUT A WRENCH, IN A BAG WAS RECEIVED. THE SAMPLE WAS VISUALLY INSPECTED AND FOUND TO BE NONCONFORMING, PHACO TIP WAS BROKEN AT THE CONE TO TRANSITION AREA, BREAKAGE IS STRAIGHT. UNEVEN WALL THICKNESS OBSERVED. WEAR OBSERVED ON THREADS, BACK OF FLANGE, AND NUT CORNERS CONSISTENT WITH THREADING ON HANDPIECE. FUNCTIONAL TEST WAS PERFORMED TO CHECK THE THREADS AND GO AND NO-GO THREAD CHECK WERE CONFORMING TO SPECIFICATIONS. NO LOT NUMBER WAS IDENTIFIED WITH THIS COMPLAINT; THEREFORE, A DEVICE HISTORY RECORD REVIEW COULD NOT BE CONDUCTED. THE COMPLAINT EVALUATION CONFIRMS THE PHACO TIP IS BROKEN. THE REASON FOR BREAKAGE IS DUE TO A UNEVEN WALL THICKNESS CREATING A WEAK REGION AT THE THINNER SECTION. THE UNEVEN WALL THICKNESS IS A MANUFACTURING ISSUE CREATED AT THE MACHINING PROCESS FOR THE PHACO TIPS. THE PHACO TIP WAS FUNCTIONALLY CONFORMING FOR THE THREAD CHECK, THEREFORE MORE VIBRATIONS THAN NORMAL WAS NOT CONFIRMED. AND A ROOT CAUSE COULD NOT BE DETERMINED. A CONTRIBUTING FACTOR TO THE REPORT OF A BIT MORE VIBRATIONS IN THE PHACO TIP THAN NORMAL COULD HAVE BEEN THE BROKEN PHACO. AN INVESTIGATION HAS BEEN COMPLETED TO FURTHER INVESTIGATE THE BROKEN PHACO TIP AND UNEVEN WALL THICKNESS. NO SPECIFIC ACTION WITH REGARD TO MORE VIBRATION IN THE PHACO TIP THAN NORMAL COMPLAINT WAS TAKEN BECAUSE THE TIP WAS FOUND FUNCTIONALLY CONFORMING FOR THE THREADS. ALL PHACO TIPS ARE 100% VISUALLY INSPECTED BY TRAINED OPERATORS USING 30X MAGNIFICATION THROUGHOUT THE MANUFACTURING PROCESS. COMPLAINTS ARE REVIEWED AND MONITORED AT REGULAR INTERVALS FOR ANY SIGNIFICANT ADVERSE TRENDS. 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

    BASED ON INFORMATION RECEIVED FOLLOWING SUBMISSION OF THE INITIAL REPORT, THE PRODUCT HAS BEEN CHANGED FROM THE PHACO TIP TO PROCEDURE PAK, MANUFACTURING SITE HAS BEEN CHANGED FROM APD, SINKING SPRING TO HTX, HOUSTON.

    Description of Event or Problem · 0

    A SURGEON REPORTED MORE VIBRATIONS IN THE PHACOEMULSIFICATION TIP THAN NORMAL AND HAD TO USE MORE ULTRASOUND EFFECT THAN NORMAL DURING SURGERY. VIBRATIONS INCREASED WHEN IT WAS MOVED FROM SCULPT TO CHOP. ASPIRATION WORKED AS NORMAL. THE PHACOEMULSIFICATION TIP WAS BROKEN IN TWO PIECES. THE SURGERY WAS COMPLETED ON THE SAME DAY WITHOUT CHANGING ANY INSTRUMENTS/ACCESSORIES WITH PATIENT CONTACT. THERE WAS NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2137754 CENTURION SURGICAL PROCEDURE PAK GENERAL SURGERY TRAY (KIT) LRO ALCON RESEARCH, LLC - HOUSTON NA ASKU 00380657522002
    2185851 CENTURION SURGICAL PROCEDURE PAK GENERAL SURGERY TRAY (KIT) LRO ALCON RESEARCH, LLC - HOUSTON NA ASKU 00380657522002

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown PHACO TIP