BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CENTURION SURGICAL PROCEDURE PAK

    MDR report key: 18108243 · Received November 9, 2023

    Report

    Report Number
    1644019-2023-01598
    Event Type
    Malfunction
    Date Received
    November 9, 2023
    Report Date
    March 4, 2024
    Manufacturer
    ALCON RESEARCH, LLC - HOUSTON
    Product Code
    LRO
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    003

    Narratives

    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).

    Additional Manufacturer Narrative · 0

    MANUFACTURER REPORT NUMBER CORRECTED AND REPORTED UNDER 2523835-2023-00729. NO FURTHER REPORTS WILL BE SCHEDULED UNDER MFG REPORT NUM. 1644019-2023-01598. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION IS PROVIDED IN SECTIONS H.10. THE INITIAL DECISION TO REPORT WAS INCORRECT RESULTING IN THE INITIAL REPORT BEING SUBMITTED IN ERROR, THE REPORTED EVENTS WERE PERTAINING TO THE 2.2 MM OPHTHALMIC KNIFE, NOT THE 1.2 MM KNIFE AS ORIGINALLY STATED. HENCE, ALL THE INFORMATION WILL BE SUBMITTED UNDER THE MFG REPORT NUM 2523835-2023-00681 AND NO FURTHER REPORTS BE SUBMITTED UNDER THE MFG REPORT NUM 1644019-2023-01598. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Description of Event or Problem · 0

    A CUSTOMER REPORTED THAT SCALPEL DID NOT CUT. THERE WERE NO OTHER DETAILS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    92309 CENTURION SURGICAL PROCEDURE PAK GENERAL SURGERY TRAY (KIT) LRO ALCON RESEARCH, LLC - HOUSTON NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown CUSTOM-PAK SURGICAL PROCEDURE PACK