BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRATHANME DAWSON-MUELLER MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER

    MDR report key: 24222305 · Received January 30, 2026

    Report

    Report Number
    1820334-2026-00108
    Event Type
    Malfunction
    Date Received
    January 30, 2026
    Date of Event
    January 27, 2026
    Report Date
    May 8, 2026
    Manufacturer
    COOK INC
    Product Code
    GBO
    UDI-DI
    00827002123847
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    D4 - CATALOG #: ULT8.5-38-25-P-5S-CLDM-TONG-05039 G4 - PMA/510(K) #: EXEMP H3 - DEVICE EVALUATED BY MFG?: DEVICE EVALUATION ANTICIPATED BUT HAS NOT YET BEGUN. AWAITING DEVICE RETURN. 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

    IT WAS REPORTED THAT THE STIFFENING CANNULA OF AN ULTRATHANE DAWSON-MUELLER MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER WAS DIFFICULT TO REMOVE DURING AN UNKNOWN PROCEDURE FOR AN UNKNOWN PATIENT. FOLLOWING INSERTION OF THE CATHETER INTO THE BILE DUCT, THE PHYSICIAN ATTEMPTED TO REMOVE THE STIFFENING CANNULA FROM THE CATHETER; HOWEVER, IT WOULD NOT COME OUT. THE CATHETER WAS THEN REMOVED FROM THE PATIENT, AND THE PROCEDURE WAS COMPLETED WITH A NEW PRODUCT OF THE SAME CATALOG NUMBER. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    238753 ULTRATHANME DAWSON-MUELLER MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER GBO; CATHETER, NEPHROSTOMY, GENERAL & PLASTIC SURGERY GBO COOK INC G12384 16894075 00827002123847

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown