BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CVAC ASPIRATION SYSTEM

    MDR report key: 25223333 · Received May 19, 2026

    Report

    Report Number
    3014683069-2026-00019
    Event Type
    Malfunction
    Date Received
    May 19, 2026
    Date of Event
    April 21, 2026
    Report Date
    May 14, 2026
    Manufacturer
    CALYXO, INC.
    Product Code
    FED
    PMA / PMN Number
    K233472
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED FOR INVESTIGATION AND REVEALED THAT THE DORNIER 12/14FR ACCESS SHEATH WAS STILL CONNECTED TO THE DEVICE. THE INVESTIGATION CONCLUDED THE DEVICE EXPERIENCED MECHANICAL STRESSES DURING THE PROCEDURE CAUSING DAMAGE TO THE HYPOTUBE, LEADING TO A TEAR IN THE IRRIGATION LUMEN JACKET, STEERING DAMAGE, AND DEFORMATION OF THE VACUUM LUMEN. THE PRODUCT LABELING, CVAC ASPIRATION SYSTEM IFU, L00018, HAS APPROPRIATE WARNINGS AND CAUTIONS AND INDICATES IF DAMAGE TO THE CVAC ASPIRATION SYSTEM OCCURS, OR IT STOPS FUNCTIONING DURING A PROCEDURE, STOP USING THE DEVICE IMMEDIATELY, TROUBLESHOOT, AND CONTINUE THE PROCEDURE WITH A NEW DEVICE, AS APPROPRIATE. THE LOT HISTORY REVIEW (LHR) FOR LOT# 90589521 WAS CONDUCTED, WHICH CONFIRMED THERE WERE NO NON-CONFORMANCES DURING THE MANUFACTURING PROCESS THAT COULD BE RELATED TO THE REPORTED EVENT. THE REVIEW INDICATED THE DEVICE MET ALL DESIGN AND MANUFACTURING SPECIFICATIONS WHEN RELEASED FOR DISTRIBUTION. CALYXO WILL CONTINUE TO PERFORM PRODUCT MONITORING AS PART OF OUR POST MARKET SURVEILLANCE PROCEDURES.

    Description of Event or Problem · 0

    ON (B)(6) 2026 A MALE PATIENT UNDERWENT A STEERABLE URETEROSCOPIC RENAL EVACUATION (SURE) PROCEDURE. IT WAS REPORTED THE DEVICE COULD NOT BE WITHDRAWN FROM THE URETERAL ACCESS SHEATH (UAS), REQUIRING THE DEVICE AND UAS TO BE REMOVED FROM THE PATIENT TOGETHER. A NEW ACCESS SHEATH AND DEVICE WAS OPENED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO PATIENT HARM WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    88194 CVAC ASPIRATION SYSTEM ENDOSCOPIC ACCESS OVERTUBE, GASTROENTEROLOGY - UROLOGY FED CALYXO, INC. CVC127020-1 90589521

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male ACCESS SHEATH: DORNIER 12/14FR.