INTEGRAL FILIFORM URETHRAL DILATOR
Report
- Report Number
- 1820334-2024-01026
- Event Type
- Malfunction
- Date Received
- August 9, 2024
- Date of Event
- July 11, 2024
- Report Date
- November 11, 2024
- Manufacturer
- COOK INC
- Product Code
- FBW
- UDI-DI
- 00827002179097
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN OR UNAVAILABLE. E1: POSTAL CODE: (B)(6). 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.
INVESTIGATION ¿ EVALUATION. IT WAS REPORTED "A PIECE" OF THE INTEGRAL FILIFORM URETHRAL DILATOR BROKE OFF DURING A URETHRAL DILATION PROCEDURE ON (B)(6) 2024. ON (B)(6) 2024, THE PATIENT UNDERWENT AN OPTICAL URETHROTOMY AND SCOPE PROCEDURE FOR TREATMENT OF URETHRAL STRICTURE. FOLLOWING THE PROCEDURE, THE DEVICE COULD BE ADVANCED WITHOUT DIFFICULTY ALLOWING THE PATIENT TO SELF-DILATE AS NEEDED AT HOME. IN (B)(6), AS THE PATIENT PERFORMED A SELF-URETHRAL DILATION PROCEDURE AT THE PATIENT¿S RESIDENCE, THE DEVICE SEPARATED IN THE PATIENT¿S URETHRA. THE SEPARATED SECTION OF THE DEVICE WAS REMOVED BY THE PATIENT WITHOUT THE USE OF ANY ADDITIONAL INSTRUMENTS. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. REVIEWS OF THE COMPLAINT HISTORY, DEVICE HISTORY RECORD (DHR), INSTRUCTIONS FOR USE (IFU), MANUFACTURER¿S INSTRUCTIONS (MI), AND QUALITY CONTROL (QC) PROCEDURES, AS WELL AS A VISUAL INSPECTION OF THE RETURNED DEVICE, WERE CONDUCTED DURING THE INVESTIGATION. ONE USED FILIFORM URETHRAL DILATOR WAS RETURNED FOR INVESTIGATION. IT WAS OBSERVED THAT 6 CM OF DILATOR TIP WAS SEVERED FROM REST OF DILATOR. ADDITIONALLY, 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. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) FOUND NO RELATED NON-CONFORMANCES REPORTED FOR LOT. A COMPLAINT HISTORY DATABASE SEARCH SHOWED NO OTHER RELATED COMPLAINTS ASSOCIATED WITH THE FAILURE MODE FOR THE COMPLAINT DEVICE LOT. BECAUSE THERE ARE 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 FIELD AND THE DEVICE WAS MANUFACTURED TO SPECIFICATION. DUE TO THE DEVICE NOT BEING SUPPLIED WITH INSTRUCTIONS FOR USE (IFU), COOK DID NOR REVIEW THE IFU. BASED UPON THE AVAILABLE INFORMATION, INSPECTION OF THE RETURNED DEVICE, AND RESULTS OF THE INVESTIGATION, COOK HAS CONCLUDED THAT THE CAUSE FOR THE COMPLAINT COULD NOT BE ESTABLISHED. THE APPROPRIATE PERSONNEL HAVE BEEN NOTIFIED AND COOK WILL CONTINUE TO MONITOR FOR SIMILAR EVENTS. PER THE QUALITY ENGINEERING 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.
BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, UNAVAILABLE, OR UNCHANGED. 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.
IT WAS REPORTED "A PIECE" OF THE INTEGRAL FILIFORM URETHRAL DILATOR BROKE OFF DURING A URETHRAL DILATION PROCEDURE ON (B)(6) 2024. ON FEBRUARY 14, 2024, THE PATIENT UNDERWENT A OPTICAL URETHROTOMY AND SCOPE PROCEDURE FOR TREATMENT OF URETHRAL STRICTURE. FOLLOWING THE PROCEDURE, THE DEVICE COULD BE ADVANCED WITHOUT DIFFICULTY ALLOWING THE PATIENT TO SELF-DILATE AS NEEDED AT HOME. IN JULY, AS THE PATIENT PERFORMED A SELF-URETHRAL DILATION PROCEDURE AT THE PATIENT¿S RESIDENCE, THE DEVICE SEPARATED IN THE PATIENT¿S URETHRA. THE SEPARATED SECTION OF THE DEVICE WAS REMOVED BY THE PATIENT WITHOUT THE USE OF ANY ADDITIONAL INSTRUMENTS. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE.
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
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 |
|---|---|---|---|---|---|---|---|
| 1935415 | INTEGRAL FILIFORM URETHRAL DILATOR | FBW FILIFORM AND FILIFORM FOLLOWER | FBW | COOK INC | G17909 | 15465224 | 00827002179097 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 77 YR | Male |