BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRATHANE COPE NEPHROURETEROSTOMY SET

    MDR report key: 10692160 · Received October 16, 2020

    Report

    Report Number
    1820334-2020-01882
    Event Type
    Malfunction
    Date Received
    October 16, 2020
    Report Date
    January 15, 2021
    Manufacturer
    COOK INC
    Product Code
    FAD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION ¿ EVALUATION. (B)(6) HOSPITAL (UNITED STATES) INFORMED COOK ON 08OCT2020 THAT THE FLEXIBLE STIFFENER IN AN UNKNOWN ULTRATHANE COPE NEPHROURETEROSTOMY SET WAS DIFFICULT TO REMOVE FROM THE CATHETER. THE FACILITY REPORTED THAT THE CATHETER "ACCORDIONED" WHEN THE USER TRIED TO REMOVE THE STIFFENER DURING THE PROCEDURE. THIS IS A GENERAL COMPLAINT. IT WAS REPORTED THAT ANOTHER CATHETER WAS USED TO COMPLETE THE PROCEDURES. A REVIEW OF THE COMPLAINT HISTORY, INSTRUCTIONS FOR USE (IFU), MANUFACTURING INSTRUCTIONS, AND QUALITY CONTROL OF THE DEVICE WAS CONDUCTED DURING THE INVESTIGATION. THE DEVICE WAS NOT RETURNED FOR EVALUATION. A DOCUMENT BASED INVESTIGATION EVALUATION WAS PERFORMED. A REVIEW OF THE DEVICE MASTER RECORD FOUND THAT PROPER PROCEDURES ARE IN PLACE TO IDENTIFY AND PREVENT THIS FAILURE MODE PRIOR TO DEVICE DISTRIBUTION. A REVIEW OF THE DESIGN HISTORY FILE FOUND THAT RISK MITIGATION CONTROLS ARE IN PLACE RELEVANT TO THE FAILURE MODE. A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE COMPLETED DUE TO A LACK OF LOT INFORMATION FROM THE USER FACILITY. THERE IS NO EVIDENCE TO SUGGEST THERE IS ANY NONCONFORMING PRODUCT IN HOUSE OR OUT IN THE FIELD. ADDITIONALLY, A REVIEW OF THE PRODUCT LABELING FOR THE DEVICE WAS COMPLETED. THE INSTRUCTIONS FOR USE STATE THE FOLLOWING INSTRUCTIONS RELATED TO THE REPORTED FAILURE MODE: "UPON REMOVAL FROM PACKAGE, INSPECT THE PRODUCT TO ENSURE NO DAMAGE HAS OCCURRED." BASED ON THE INFORMATION PROVIDED AND THE RESULTS OF THE INVESTIGATION, A DEFINITIVE CAUSE FOR THE FAILURE WAS TRACED TO COMPONENT FAILURE WITHOUT A DESIGN OR MANUFACTURING ISSUE. THE APPROPRIATE PERSONNEL HAVE BEEN NOTIFIED. PER THE QUALITY ENGINEERING RISK ASSESSMENT, NO FURTHER ACTION IS REQUIRED. COOK WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS. 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, THAT A DEATH OR SERIOUS INJURY OCCURRED, NOR THAT ANY COOK DEVICE CAUSED, 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

    NO ADDITIONAL PATIENT/EVENT INFORMATION HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

    Additional Manufacturer Narrative · 1

    OCCUPATION: UNKNOWN. PMA/510(K) #: K171603. 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 AN UNKNOWN PATIENT REQUIRED PLACEMENT OF AN ULTRATHANE COPE NEPHROURETERECTOMY SET FOR AN UNKNOWN PROCEDURE. DURING THE PROCEDURE, THE DILATOR WAS DIFFICULT TO REMOVE AND THE CATHETER KINKED AND ACCORDIONED. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE NUMBER OF DEVICES EXPERIENCING THIS FAILURE IS UNKNOWN. AS REPORTED, 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
    1155706 ULTRATHANE COPE NEPHROURETEROSTOMY SET FAD STENT, URETERAL FAD COOK INC N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1