BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CVAC ASPIRATION SYSTEM

    MDR report key: 23383955 · Received October 24, 2025

    Report

    Report Number
    3014683069-2025-00029
    Event Type
    Malfunction
    Date Received
    October 24, 2025
    Date of Event
    August 25, 2025
    Report Date
    October 24, 2025
    Manufacturer
    CALYXO INC.
    Product Code
    FED
    PMA / PMN Number
    K233472
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED FOR INVESTIGATION WHICH CONCLUDED THAT BURN DAMAGE TO THE CVAC ASPIRATION SYSTEM WAS RELATED TO USE ERROR OF THE LASER SYSTEM (A NON CALYXO DEVICE) WHILE WITHIN THE WORKING CHANNEL OF THE CVAC SYSTEM. THE CVAC ASPIRATION SYSTEM IFU HAS A WARNING STATEMENT: "DO NOT ACTIVATE A LASER WITH A LASER FIBER TIP WITHIN THE LUMEN OF THE CVAC ASPIRATION SYSTEM. DOING SO MAY CAUSE PATIENT INJURY AND/OR DAMAGE TO THE CVAC ASPIRATION SYSTEM." THE LOT HISTORY REVIEW (LHR) FOR LOT # 82459709 WAS CONDUCTED, WHICH CONFIRMED THAT THERE WERE NO NON-CONFORMANCES OBSERVED AT THE TIME OF MANUFACTURE RELATED TO THE REPORTED EVENT. THE REVIEW INDICATED THAT THE DEVICE MET ALL DESIGN AND MANUFACTURING SPECIFICATIONS WHEN RELEASED FOR DISTRIBUTION.

    Description of Event or Problem · 0

    ON (B)(6) 2025, A 34-YEAR-OLD MALE PATIENT UNDERWENT A STEERABLE URETEROSCOPIC RENAL PROCEDURE (SURE). DURING THE PROCEDURE, A CVAC DEVICE ENCOUNTERED AN UNRESOLVED CLOG. THE DEVICE WAS REPLACED AND THE PROCEDURE WAS COMPLETED. NO PATIENT ADVERSE EVENTS WERE REPORTED. INVESTIGATION OF THE RETURNED DEVICE ON (B)(6) 2025 REVEALED DAMAGE TO THE CVAC ASPIRATION SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1790138 CVAC ASPIRATION SYSTEM ENDOSCOPIC ACCESS OVERTUBE, GASTROENTEROLOGY-UROLOGY FED CALYXO INC. CVC127020-1 82459709

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Male MOSES FIBER SIZE : 242