BEUDAMED
    FDA Adverse Event Injury Summary report: N

    URETERAL DILATOR

    MDR report key: 14655512 · Received June 10, 2022

    Report

    Report Number
    1820334-2022-01034
    Event Type
    Injury
    Date Received
    June 10, 2022
    Date of Event
    April 11, 2022
    Report Date
    October 11, 2022
    Manufacturer
    COOK INC
    Product Code
    KOE
    UDI-DI
    10827002142975
    PMA / PMN Number
    K173654
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    COMMON DEVICE NAME: EZN DILATOR, CATHETER, URETERAL. 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, UNCHANGED, OR UNAVAILABLE. EVENT DESCRIPTION: AS REPORTED, DURING A FIBROSCOPY IN THE RENAL PELVIS AND URETER, THE TIP ON A 14FR URETERAL DILATOR SEPARATED IN THE PATIENT'S URETER. THE USER DILATED THE STENOSED URETERAL ORIFICE AND INSERTED AN UNSPECIFIED RIGID CYSTOSCOPE TO PREVENT THE URETERAL DILATOR FROM "BOWING" IN THE BLADDER. THE RIGID CYSTOSCOPE WAS REMOVED LEAVING THE OUTER TUBE OF THE CYSTOSCOPE TO PROVIDE SUPPORT TO THE DILATOR. A 6FR DILATOR WAS THEN PLACED OVER AN UNSPECIFIED WIRE GUIDE TO CONTINUE DILATION. "STRONG RESISTANCE" WAS FELT UPON REMOVAL AND INSERTION OF THE 14FR DILATOR. THE USER INSPECTED THE REMOVED 14FR DILATOR OUTSIDE THE PATIENT'S BODY AND NOTICED THE TIP WAS SEPARATED. THE TIP WAS CONFIRMED TO HAVE REMAINED INSIDE THE PATIENT'S BODY, SO THE USER RE DILATED THE URETERAL ORIFICE TO PERFORM A RESECTION. FORCEPS WERE USED TO REMOVED THE SEPARATED TIP FROM THE PATIENT SUCCESSFULLY. THE PROCEDURE WAS NOT ABLE TO COMPLETED DUE TO A KINK AND STENOSIS IN THE UPPER PART OF THE URETER, WHICH WAS NOTED TO NOT BE RELATED TO THE SEPARATED DILATOR TIP. THE USER BELIEVES THAT THE FRICTION BETWEEN THE OUTER TUBE OF THE RIGID CYSTOSCOPE AND THE COMPLAINT DEVICE CONTRIBUTED THE SEPARATION, NOTING THEY DO NOT BELIEVE THIS TO BE A "DEVICE DEFECT." NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED. INVESTIGATION ¿ EVALUATION A VISUAL INSPECTION OF THE RETURNED DEVICE WAS CONDUCTED. A DOCUMENT BASED INVESTIGATION WAS ALSO PERFORMED INCLUDING A REVIEW OF COMPLAINT HISTORY, DEVICE HISTORY RECORD (DHR), THE INSTRUCTIONS FOR USE (IFU), AND QUALITY CONTROL PROCEDURES. ONE SET OF URETERAL DILATORS WAS RETURNED IN AN OPEN INNER TRAY, WITH NO OTHER ORIGINAL PACKAGING. A 14F DILATOR WAS RETURNED IN 2 SEGMENTS. THE TIP SEGMENT IS APPROXIMATELY 6CM LONG. THE MAIN BODY SEGMENT IS APPROXIMATELY 55.54CM. THE POINT OF SEPARATION WAS ANGLED, WITH A RAGGED AND STRETCHED APPEARANCE. THE OTHER DILATORS FROM THE SET HAD NO CORRESPONDING DAMAGE. THE PACKAGING TRAY WAS ALSO FREE OF DAMAGE. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO NON-CONFORMANCES RELATED TO THE REPORTED FAILURE MODE. A REVIEW OF COMPLAINT HISTORY RECORDS SHOWS NO OTHER COMPLAINTS ASSOCIATED WITH THE COMPLAINT DEVICE LOT. BECAUSE THERE WERE NO RELATED NON-CONFORMANCES, ADEQUATE INSPECTION ACTIVITIES HAVE BEEN ESTABLISHED, THERE IS OBJECTIVE EVIDENCE THAT THE DHR WAS FULLY EXECUTED, AND NO OTHER LOT RELATED COMPLAINTS THAT HAVE BEEN RECEIVED FROM THE FIELD, IT WAS CONCLUDED THAT THERE IS NO EVIDENCE THAT NONCONFORMING PRODUCT EXISTS IN HOUSE OR IN THE FIELD. A REVIEW OF RELEVANT MANUFACTURING AND QUALITY CONTROL DOCUMENTS WAS CONDUCTED. ALL DILATORS ARE VISUALLY INSPECTED. COOK HAS CONCLUDED THAT SUFFICIENT INSPECTION ACTIVITIES ARE IN PLACE TO IDENTIFY THIS FAILURE MODE PRIOR TO DISTRIBUTION. THE INSTRUCTIONS FOR USE (IFU), DOES NOT PROVIDE ANY INFORMATION TO THE USER RELATED TO THE REPORTED FAILURE. THE PROVIDED INFORMATION STATES THE USER WAS PERFORMING THE PROCEDURE WHILE LEAVING THE OUTER TUBE OF THE RIGID CYSTOSCOPE IN PLACE. THE USER STATED THAT FRICTION BETWEEN THE OUTER TUBE OF RIGID CYSTOSCOPE USED AS 'SUPPORT SHEATH' AND THE DILATOR CAUSED DAMAGE AND THE DAMAGE LED TO BREAKAGE AND THE DEVICE WAS NOT DEFECTIVE. BASED ON THE INFORMATION PROVIDED BY THE USER, THE CAUSE OF THE COMPLAINT WAS DETERMINED TO BE THAT IT WAS AN ADVERSE EVENT RELATED TO THE PROCEDURE. PER THE QUALITY ENGINEERING RISK ASSESSMENT, NO FURTHER ACTION IS REQUIRED. THE APPROPRIATE PERSONNEL HAVE BEEN NOTIFIED, AND WE WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS. 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

    AS REPORTED, DURING A FIBROSCOPY IN THE RENAL PELVIS AND URETER, THE TIP ON A 14FR URETERAL DILATOR SEPARATED IN THE PATIENT'S URETER. THE USER DILATED THE STENOSED URETERAL ORIFICE AND INSERTED AN UNSPECIFIED RIGID CYSTOSCOPE TO PREVENT THE URETERAL DILATOR FROM "BOWING" IN THE BLADDER. THE RIGID CYSTOSCOPE WAS REMOVED LEAVING THE OUTER TUBE OF THE CYSTOSCOPE TO PROVIDE SUPPORT TO THE DILATOR. A 6FR DILATOR WAS THEN PLACED OVER AN UNSPECIFIED WIRE GUIDE TO CONTINUE DILATION. "STRONG RESISTANCE" WAS FELT UPON REMOVAL AND INSERTION OF THE 14FR DILATOR. THE USER INSPECTED THE REMOVED 14FR DILATOR OUTSIDE THE PATIENT'S BODY AND NOTICED THE TIP WAS SEPARATED. THE TIP WAS CONFIRMED TO HAVE REMAINED INSIDE THE PATIENT'S BODY, SO THE USER RE DILATED THE URETERAL ORIFICE TO PERFORM A RESECTION. FORCEPS WERE USED TO REMOVED THE SEPARATED TIP FROM THE PATIENT SUCCESSFULLY. THE PROCEDURE WAS NOT ABLE TO COMPLETED DUE TO A KINK AND STENOSIS IN THE UPPER PART OF THE URETER, WHICH WAS NOTED TO NOT BE RELATED TO THE SEPARATED DILATOR TIP. THE USER BELIEVES THAT THE FRICTION BETWEEN THE OUTER TUBE OF THE RIGID CYSTOSCOPE AND THE COMPLAINT DEVICE CONTRIBUTED THE SEPARATION, NOTING THEY DO NOT BELIEVE THIS TO BE A "DEVICE DEFECT." NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

    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
    630633 URETERAL DILATOR KOE DILATOR, URETHRAL KOE COOK INC 14451853 10827002142975

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention