BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRATHANE COPE NEPHROURETEROSTOMY SET

    MDR report key: 15330770 · Received August 31, 2022

    Report

    Report Number
    1820334-2022-01433
    Event Type
    Malfunction
    Date Received
    August 31, 2022
    Report Date
    February 13, 2023
    Manufacturer
    COOK INC
    Product Code
    FAD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ND, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    OCCUPATION: BSRT(R)(VI). 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. 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

    BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, UNAVAILABLE, OR UNCHANGED. INVESTIGATION ¿ EVALUATION ON (B)(6) 2022, COOK MEDICAL INC. RECEIVED A COMPLAINT FROM A REPRESENTATIVE AT THE ST ALEXIUS MEDICAL CENTER LOCATED IN THE CITY OF BISMARK, ND. DURING A PROCEDURE WHERE A ULTRATHANE COPE NEPHROURETEROSTOMY SET (RPN: (B)(4) , LOT NUMBER: 14321527) WAS USED, THE PHYSICIAN ENCOUNTERED DIFFICULTY WHEN ATTEMPTING TO REMOVE THE FLEXIBLE STIFFENER (REFERENCED IN MFG REPORT REFERENCE #: (B)(4)). THIS INVESTIGATION WILL CAPTURE SIMILAR INCIDENTS THE CUSTOMER MENTIONED OCCURRING AFTER WITH THE OTHER UNKNOWN ULTRATHANE COPE NEPHROURETEROSTOMY SETS. IT IS UNKNOWN IF THE PATIENT(S) EXPERIENCED ANY ADVERSE EFFECTS DUE TO THESE OCCURRENCES. REVIEWS OF DOCUMENTATION INCLUDING THE COMPLAINT HISTORY, DEVICE HISTORY RECORD, INSTRUCTIONS FOR USE (IFU), QUALITY CONTROL PROCEDURES, AND REVIEW OF SPECIFICATION FOR THE COMPLAINT DEVICE WERE CONDUCTED DURING THE INVESTIGATION. THE COMPLAINT DEVICE WAS NOT RETURNED; THEREFORE, NO PHYSICAL EXAMINATIONS COULD BE PERFORMED. HOWEVER, A DOCUMENT-BASED INVESTIGATION EVALUATION WAS PERFORMED. A REVIEW OF THE DEVICE MASTER RECORD (DMR) CONCLUDED THAT SUFFICIENT INSPECTION ACTIVITIES ARE IN PLACE TO IDENTIFY THIS FAILURE MODE PRIOR TO DISTRIBUTION. THE CUSTOMER DID NOT PROVIDE THE LOT NUMBER FOR THE COMPLAINT DEVICES. COOK REVIEWED THE SALES HISTORY FOR THIS CUSTOMER AND WAS UNABLE TO IDENTIFY THE COMPLAINT LOT. THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED. BASED ON THIS INFORMATION, THE DEVICE WAS MANUFACTURED TO SPECIFICATION. THERE IS NO EVIDENCE OF NONCONFORMING MATERIAL IN HOUSE OR IN THE FIELD. COOK ALSO REVIEWED PRODUCT LABELING. THE IFU, T_NUCL_REV4, PACKAGED WITH THE DEVICE CONTAINS THE FOLLOWING IN RELATION TO THE REPORTED FAILURE MODE: "PRECAUTIONS: WHEN INSERTING A STIFFENING CANNULA INTO THE CATHETER WITH RETENTION SUTURE, HOLD SUTURE DURING CANNULA INSERTION TO AVOID BUNCHING OR TANGLING OF THE SUTURE." BASED ON THE INFORMATION PROVIDED, NO PRODUCT RETURNED, AND THE RESULTS OF THE INVESTIGATION, COOK MEDICAL HAS CONCLUDED THAT COMPONENT FAILURE UNRELATED TO MANUFACTURING OR DESIGN DEFICIENCIES CONTRIBUTED TO THIS INCIDENT. THE APPROPRIATE PERSONNEL HAVE BEEN NOTIFIED. COOK WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS. PER THE RISK ASSESSMENT NO FURTHER ACTION IS REQUIRED. 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

    IT WAS REPORTED THAT THERE WERE TWO OCCURRENCES WHERE THE FLEXIBLE STIFFENERS WERE DIFFICULT TO REMOVE FROM THE CATHETERS OF UNKNOWN ULTRATHANE COPE NEPHROURETERECTOMY SETS. THEY WERE DESCRIBED BY THE USER AS "NOT AS SLIPPERY AS THEY USED TO BE". NO ADVERSE EFFECTS WERE REPORTED FOR THESE INCIDENTS.

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1774073 ULTRATHANE COPE NEPHROURETEROSTOMY SET FAD STENT, URETERAL FAD COOK INC N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown