BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONSTELLATION SURGICAL PROCEDURE PACK

    MDR report key: 18866416 · Received March 8, 2024

    Report

    Report Number
    1644019-2024-00429
    Event Type
    Malfunction
    Date Received
    March 8, 2024
    Date of Event
    February 2, 2024
    Report Date
    June 10, 2024
    Manufacturer
    ALCON RESEARCH, LLC - HOUSTON
    Product Code
    LRO
    UDI-DI
    00380657524372
    PMA / PMN Number
    K880961
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    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

    UPON FURTHER CONFIRMATION WITH RESPECT TO THE FILE REPORTING CUTTER WAS NOT FUNCTIONING (NO FUNCTION/NO ACTION AT ALL WITH THE CUTTER) DURING SURGERY IS NOT TO BE CONSIDERED A REPORTABLE MALFUNCTION BECAUSE A SERIOUS INJURY HAS NOT OCCURRED AND IT IS NOT LIKELY THAT A RECURRENCE WOULD RESULT IN SERIOUS INJURY.

    Description of Event or Problem · 0

    A NON HEALTH CARE PROFESSIONAL REPORTED THAT THE CUTTER WAS NOT FUNCTIONING (NO FUNCTION/NO ACTION AT ALL WITH THE CUTTER) DURING SURGERY. THE SURGERY WAS COMPLETED AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. THE PROCEDURE TYPE WAS UNKNOWN. THERE WAS NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2342116 CONSTELLATION SURGICAL PROCEDURE PACK GENERAL SURGERY TRAY (KIT) LRO ALCON RESEARCH, LLC - HOUSTON NA 166A37 00380657524372

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown