BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    C-FLEX MULTI-LENGTH URETERAL STENT SET

    MDR report key: 9626691 · Received January 24, 2020

    Report

    Report Number
    1820334-2020-00192
    Event Type
    Malfunction
    Date Received
    January 24, 2020
    Date of Event
    December 25, 2019
    Report Date
    February 27, 2020
    Manufacturer
    COOK INC
    Product Code
    FAD
    UDI-DI
    00827002155329
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    THE EVENT IS CURRENTLY UNDER INVESTIGATION. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON RECEIPT OF ADDITIONAL INFORMATION OR COMPLETION OF THE INVESTIGATION. 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 COOK DEVICE CAUSED OR CONTRIBUTED TO; OR IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF A MALFUNCTION OCCURRED.

    Additional Manufacturer Narrative · 0

    AFTER RECEIPT OF THE COMPLAINT DEVICE AND INITIAL OBSERVATION, IT WAS NOTED THAT THERE WAS NO FRACTURE OF THE STENT DEVICE. THEREFORE, NO REPORTABLE DEVICE MALFUNCTION OR SERIOUS INJURY OCCURRED, AND THIS COMPLAINT IS NOW CONSIDERED NONREPORTABLE. 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 COOK 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

    ADDITIONAL INFORMATION RECEIVED ON 03FEB2020: THE FRACTURE WAS DISCOVERED UPON INSPECTION OF THE STENT AS IT WAS REMOVED FROM THE PACKAGING AT THE SCRUB TABLE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED BY USING ANOTHER STENT.

    Description of Event or Problem · 0

    NO NEW PATIENT OR EVENT INFORMATION SINCE THE LAST REPORT WAS SUBMITTED.

    Additional Manufacturer Narrative · 1

    PMA/510K #: K162104. THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED, DURING A STENT INSERTION VIA THE BLADDER USING A C-FLEX MULTI-LENGTH URETERAL STENT SET, THE STENT FRACTURED AT THE DISTAL END "ON THE PERFORATION". IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED. NO SECTION OF THE DEVICE REMAINS INSIDE OF THE PATIENT. NO ADVERSE EFFECTS WERE REPORTED DUE TO THE ALLEGED MALFUNCTION. ADDITIONAL PATIENT AND EVENT INFORMATION HAS BEEN REQUESTED. NO OTHER INFORMATION IS AVAILABLE AT THIS TIME. A FOLLOW UP REPORT WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION IS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    88943 C-FLEX MULTI-LENGTH URETERAL STENT SET FAD STENT, URETERAL FAD COOK INC G15532 9258631 00827002155329

    Patients

    Seq Age Sex Outcome Treatment
    1