BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIVER ACCESS AND BIOPSY SET

    MDR report key: 24500013 · Received March 3, 2026

    Report

    Report Number
    1820334-2026-00240
    Event Type
    Malfunction
    Date Received
    March 3, 2026
    Date of Event
    March 15, 2025
    Report Date
    April 6, 2026
    Manufacturer
    COOK INC
    Product Code
    FCG
    UDI-DI
    00827002507791
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SG
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    . ADDITIONAL INFORMATION: B5 CORRECTION: H6 - ANNEX F. THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW-UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE. THIS REPORT IS REQUIRED BY THE FDA UNDER 21 CFR PART 803 AND IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT CONTAINED HEREIN IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED OR THAT A DEATH OR SERIOUS INJURY OCCURRED; NOR IS IT ADMISSION THAT ANY COOK DEVICE CAUSED, CONTRIBUTED TO, OR IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF A MALFUNCTION OCCURRED.

    Additional Manufacturer Narrative · 0

    E1 - PHONE: (B)(6). G4 - PMA/510(K): PREAMENDMENT. H3 - DEVICE EVALUATED BY MFG?: THE COMPLAINT DEVICE WAS NOT RETURNED FOR EVALUATION. THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE. THIS REPORT IS REQUIRED BY THE FDA UNDER 21 CFR PART 803. THIS REPORT IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT MADE IN IT IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED; THAT A DEATH OR SERIOUS INJURY OCCURRED; OR THAT ANY DEVICE CAUSED OR CONTRIBUTED TO; OR IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF A MALFUNCTION OCCURRED.

    Description of Event or Problem · 0

    IN ADDITIONAL INFORMATION, IT WAS REPORTED THAT THE BIOPSY NEEDLE HAD NOT YET BEEN ADVANCED THROUGH THE CATHETER; THE USER WAS STILL ADVANCING THE SHEATH AND CATHETER. THE PROBLEM WAS WITH PATIENT ANATOMY AND A HARD CIRRHOTIC LIVER. A SIMILAR ISSUE HAPPENED WITH "NUHS GUYS" WHEN THEY ALSO ATTEMPTED. A SMALL PORTION OF THE CATHETER SEPARATED WHILE ADVANCING OVER THE STIFF WIRE; HOWEVER, THE FRAGMENT WAS SEEN ON FLUOROSCOPY IN THE PULMONARY ARTERY AND WAS SUCCESSFULLY SNARED AND RETRIEVED FROM THE PATIENT. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT TIP OF THE CURVED CATHETER INCLUDED IN THE LIVER ACCESS AND BIOPSY SET SEPARATED WHILE OBTAINING LIVER HISTOLOGY SAMPLES VIA JUGULAR VEIN APPROACH FOR AN UNKNOWN PATIENT. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ADDITIONAL INFORMATION REGARDING EVENT DETAILS HAS BEEN REQUESTED BUT IS CURRENTLY UNAVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    592978 LIVER ACCESS AND BIOPSY SET FCG; BIOPSY NEEDLE FCG COOK INC G50779 16237960 00827002507791

    Patients

    Seq Age Sex Outcome Treatment
    1