BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CENTURION SURGICAL PROCEDURE PAK

    MDR report key: 19664351 · Received July 3, 2024

    Report

    Report Number
    1644019-2024-01437
    Event Type
    Malfunction
    Date Received
    July 3, 2024
    Report Date
    October 29, 2024
    Manufacturer
    ALCON RESEARCH, LLC - HOUSTON
    Product Code
    LRO
    UDI-DI
    00380657522125
    PMA / PMN Number
    K880961
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION PROVIDED IN D.9., H.3., H.6. AND H.11. 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 WET FLUIDICS MANAGEMENT SYSTEM (FMS) IN A TRAY WAS VISUALLY INSPECTED AND WAS TESTED USING A CONSOLE. THE SAMPLE COULD BE RECOGNIZED BY THE CONSOLE. THE SAMPLE PRIMED AND TUNED WITH A HANDPIECE AND A 0.9 MILLIMETER ASPIRATION BYPASS SYSTEM (ABS) TIP AND INFUSION SLEEVE FROM LAB STOCK, SUCCESSFULLY AND THE SERVICE DATA COULD BE RETRIEVED. NO SYSTEM MESSAGE CODE DISPLAYED ON CONSOLE SCREEN. THE SAMPLE FUNCTIONED WITHIN SPECIFICATION. CASSETTE MAX VACUUM AND ASPIRATION FLOW RATE, AND IRRIGATION FLOW RATE WERE MEASURED AND MET SPECIFICATIONS. NO PROBLEM WAS FOUND WITH THE RETURNED CASSETTE FLUIDICS. THE ROOT CAUSE OF THE CUSTOMER'S COMPLAINT COULD NOT BE ESTABLISHED; THE RETURNED SAMPLE FUNCTIONED PER SPECIFICATION. THIS COMPLAINT HAS BEEN REVIEWED AND IT IS DETERMINED THAT NO FURTHER ACTIONS WILL BE PURSED AT THIS TIME AS THE SAMPLE MET SPECIFICATIONS. BASED ON OUR CURRENT TRACKING, THERE ARE NO ADVERSE TRENDS FOR THIS REPORTED COMPLAINT. QUALITY ASSURANCE HAS REVIEWED THIS COMPLAINT AND WILL CONTINUE TO MONITOR DATA FOR EVIDENCE OF ADVERSE TRENDING AND TAKE FURTHER ACTION, AS APPROPRIATE. 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 CUSTOMER REPORTED THAT THE CONSOLE SHOWED "NO VACUUM¿ DURING SURGERY. THE PROCEDURE TYPE WAS UNKNOWN AND THERE WAS NO PATIENT HARM.SOUTH AFRICA FINAL REPORT; 2024-46211-01, FILE ID (B)(4), QS FILE ID (B)(4).NAMES OF ANY OTHER REGULATORY AUTHORITIES TO WHICH THESE EVENTS HAVE BEEN REPORTED: U.S. FOOD AND DRUG ADMINISTRATIONDATE OF THE REPORTS: 07-JUN-2024 03:46 AMSERIAL NUMBER/LOT NUMBER: 16J632BATCH NUMBER: 16J632SOFTWARE VERSION: NACURRENT KNOWN LOCATION OF THE MEDICAL DEVICE INVOLVED IN THE EVENT: MANUFACTURERANY HCR / LICENSED MANUFACTURER, OR LICENSED DISTRIBUTOR COMMENTS: NAANY OTHER COUNTRIES IN WHICH THE MEDICAL DEVICE IS KNOWN TO BE ON SALE OR SUPPLIED: ALBANIA, ALGERIA, ARGENTINA, ARMENIA, AUSTRALIA, AZERBAIJAN, BAHRAIN, BANGLADESH, BELARUS, BRAZIL, BRUNEI DARUSSALAM, CAMBODIA, CANADA, CHILE, CHINA, COLOMBIA, DOMINICAN REPUBLIC, ECUADOR, EGYPT, GEORGIA, HONG KONG, INDIA, INDONESIA, IRAQ, ISRAEL, JAPAN, JORDAN, KAZAKHSTAN, KENYA, KOSOVO, KUWAIT, KYRGYZSTAN, LAO PEOPLE'S DEMOCRATIC REPUBLIC, LEBANON, MALAYSIA, MAURITIUS, MEXICO, MOLDOVA, MONGOLIA, MONTENEGRO, MOROCCO, MYANMAR, NAMIBIA, NEPAL, NEW ZEALAND, NORTH MACEDONIA, OMAN, OTHER-EMEA, OTHER-LACAR, PAKISTAN, PARAGUAY, PERU, PHILIPPINES, PUERTO RICO, QATAR, REPUBLIC OF KOREA, RUSSIAN FEDERATION, SAUDI ARABIA, SERBIA, SINGAPORE, SOUTH AFRICA, SRI LANKA, TAIWAN, THAILAND, TUNISIA, UKRAINE, UNITED ARAB EMIRATES, UNITED KINGDOM OF GREAT BRITAIN, UNITED STATES OF AMERICA, URUGUAY, UZBEKISTAN, VENEZUELA (BOLIVARIAN REPUBLIC OF), VIET NAM, ZAMBIA. TABLE 1: SALES DATA:SOUTH AFRICA SALES: 22678WORLDWIDE (EXCLUDING SOUTH AFRICA) SALES: 10056454SALES SEARCH CRITERIA: CENTURION SURGICAL PROCEDURE PAK FAMILY FROM JUL 01, 2023 TO JUN 30, 2024. TABLE 2A: SIMILAR EVENTS DATA (CENTURION SURGICAL PROCEDURE PAK, ASPIRATION/SUCTION ISSUE) SOUTH AFRICASIMILAR EVENTS: 6 WORLDWIDE (EXCLUDING SOUTH AFRICA) SIMILAR EVENTS: 219 SIMILAR EVENTS SEARCH CRITERIA: CENTURION SURGICAL PROCEDURE PAK FAMILY WITH EVENT CODES ASPIRATION/SUCTION ISSUE. TABLE 2B: RATE (PER 1000)SOUTH AFRICA RATE: 0.2645735 WORLDWIDE (EXCLUDING SOUTH AFRICA) RATE: 0.021777

    Description of Event or Problem · 0

    A CUSTOMER REPORTED THAT THE CONSOLE SHOWED "NO VACUUM¿ DURING SURGERY. THE PROCEDURE TYPE WAS UNKNOWN AND THERE WAS NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    570611 CENTURION SURGICAL PROCEDURE PAK GENERAL SURGERY TRAY (KIT) LRO ALCON RESEARCH, LLC - HOUSTON NA 16J632 00380657522125

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown