BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRATHANE COPE NEPHROURETEROSTOMY SET

    MDR report key: 17454736 · Received August 3, 2023

    Report

    Report Number
    1820334-2023-01019
    Event Type
    Malfunction
    Date Received
    August 3, 2023
    Date of Event
    July 26, 2023
    Report Date
    October 9, 2023
    Manufacturer
    COOK INC
    Product Code
    FAD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN OR UNAVAILABLE. E3- OCCUPATION: LEAD TECH. G4- 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 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

    BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, UNCHANGED OR UNAVAILABLE. INVESTIGATION ¿ EVALUATION ON (B)(6) 2023, COOK MEDICAL INC. RECEIVED A COMPLAINT REGARDING AN ULTRATHANE COPE NEPHROURETEROSTOMY SET (RPN: ULT8.5-8.5-22-NUCL-B-RH, LOT: UNKNOWN) FROM NAZARETH HOSPITAL. THE CUSTOMER REPORTED THE MAC-LOC ADAPTOR SEPARATED FROM THE DRAINAGE CATHETER AFTER DEVICE PLACEMENT DURING AN ATTEMPT TO SECURE THE SUTURE STRING. AN ADDITIONAL DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. REVIEWS OF THE DOCUMENTATION, INCLUDING THE DRAWING, INSTRUCTION FOR USE (IFU), QUALITY CONTROL PROCEDURES AND SPECIFICATIONS OF THE DEVICE, WERE CONDUCTED DURING THE INVESTIGATION. THE COMPLAINT DEVICE WAS NOT RETURNED FOR EVALUATION; THEREFORE, A PHYSICAL EXAMINATION COULD NOT BE CONDUCTED. 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 PREVENT THE RELEASE OF NONCONFORMING PRODUCT RELATED TO THE REPORTED FAILURE MODE. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) COULD NOT BE CONDUCTED, AS LOT INFORMATION WAS NOT PROVIDED BY THE FACILITY. AN EXPANDED SALES SEARCH WAS UNABLE TO IDENTIFY THE COMPLAINT LOT. COOK ALSO REVIEWED PRODUCT LABELING. THE IFU SUPPLIED (T_NUCL_REV5 ) "COPE NEPHROURETEROSTOMY STENTS", PROVIDES THE FOLLOWING INFORMATION TO THE USER RELATED TO THE REPORTED FAILURE MODE: HOW SUPPLIED UPON REMOVAL FROM PACKAGE, INSPECT THE PRODUCT TO ENSURE NO DAMAGE HAS OCCURRED. EVIDENCE GATHERED UPON REVIEW OF THE DMR AND IFU SUGGESTS THAT THE DEVICE WAS NOT MANUFACTURED OUT OF SPECIFICATION, AND THAT THERE ARE NO NONCONFORMING DEVICES IN HOUSE OR OUT IN THE FIELD. BASED ON THE INFORMATION PROVIDED, NO RETURNED PRODUCT, AND THE RESULTS OF OUR INVESTIGATION, IT WAS CONCLUDED THAT A COMPONENT FAILURE, WITHOUT ANY DESIGN OR MANUFACTURING ISSUE CONTRIBUTED TO THE EVENT. THE APPROPRIATE PERSONNEL HAVE BEEN NOTIFIED. PER THE RISK ASSESSMENT NO FURTHER ACTION IS REQUIRED. WE 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

    IT WAS REPORTED THAT THE DRAINAGE CATHETER OF AN ULTRATHANE COPE NEPHROURETEROSTOMY SET "BROKE OFF" FROM THE HUB WHEN TRYING TO LOCK THE DRAINAGE CATHETER DURING A PROCEDURE. MICROPUNCTURE WAS USED TO PLACE THE DRAINAGE CATHETER INTO THE KIDNEY AND BLADDER TO DRAIN URINE. DURING THE PROCEDURE, AFTER THE DRAINAGE CATHETER WAS PLACED, LEAKAGE AROUND THE HUB AND SEPARATION OF THE HUB FROM THE DRAINAGE CATHETER WAS NOTED. NOTHING HAD YET BEEN CONNECTED TO THE DEVICE. NO FORCE WAS EXERTED ON THE DRAINAGE CATHETER. THIS FAILURE OCCURRED TWICE IN THE SAME PROCEDURE WITH TWO SEPARATE DEVICES, AND THE PROCEDURE WAS COMPLETED WITH A THIRD LIKE DEVICE. THIS REPORT CAPTURES ONE OF THE DEVICES THAT SEPARATED. THE OTHER DEVICE WILL BE REPORTED UNDER THE SAME PATIENT IDENTIFIER #(B)(6). 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

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    318881 ULTRATHANE COPE NEPHROURETEROSTOMY SET FAD STENT, URETERAL FAD COOK INC N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown