COOK SINGLE-USE HOLMIUM LASER FIBER
Report
- Report Number
- 1820334-2020-00340
- Event Type
- Malfunction
- Date Received
- February 13, 2020
- Date of Event
- January 28, 2020
- Report Date
- April 2, 2020
- Manufacturer
- COOK INC
- Product Code
- GEX
- UDI-DI
- 00827002252936
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- OTHER
Narratives
THE EVENT IS CURRENTLY UNDER INVESTIGATION. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON RECEIPT OF ADDITIONAL INFORMATION OR COMPLETION OF THE INVESTIGATION. 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.
BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNCHANGED, UNKNOWN OR UNAVAILABLE. IT WAS REPORTED, DURING FLEXIBLE URETEROSCOPY IN THE KIDNEY, A COOK SINGLE-USE HOLMIUM LASER FIBER BROKE INSIDE THE FLEXIBLE SCOPE. A NEW FIBER WAS USED TO COMPLETE THE PROCEDURE. THE PATIENT DID NOT REQUIRE ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE AND NO ADVERSE EFFECTS HAS BEEN REPORTED AS A RESULT OF REPORTED ISSUE. 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, MANUFACTURING INSTRUCTIONS, THE INSTRUCTIONS FOR USE, AND QUALITY CONTROL DATA. ONE DEVICE WAS RETURNED FOR INVESTIGATION. INSPECTION OF THE RETURNED DEVICE NOTED: THE FIBER WAS RETURNED IN A USED CONDITION, THE FIBER OPTICS DID NOT PROTRUDE FROM DISTAL END OF THE BLUE JACKET, THE FIBER OPTICS WERE BROKEN WITH APPROXIMATELY 1MM OF THE BLUE JACKET EXTENDING BEYOND THE END OF THE FIBER OPTICS, CLOSE EXAMINATION OF THE POINT OF SEPARATION CONFIRMED BLACK DISCOLORATION AND CHARRING ON THE FIBER AND FIBER JACKET, THE DISTAL END OF THE JACKET APPEARED RAGGED, TORN AND SLIGHTLY MELTED, THE PLUG APPEARED SECURE, UNDAMAGED, AND THERE WAS NO DISCOLORATION. THE OVERALL LENGTH OF THE FIBER MEASURED 299.5CM. 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. A REVIEW OF RELEVANT MANUFACTURING DOCUMENTS WAS CONDUCTED. IT WAS CONCLUDED THAT THE DEVICE ASPECT IN QUESTION WAS VISUALLY/FUNCTIONALLY INSPECTED BY QUALITY CONTROL AND NO RELATED GAPS IN PRODUCTION OR PROCESSING CONTROLS WERE NOTED. THE INSTRUCTIONS FOR USE (IFU), PROVIDES THE FOLLOWING INFORMATION TO THE USER RELATED TO THE REPORTED FAILURE MODE: PRECAUTIONS A NUMBER OF DIFFERENT FACTORS AFFECT THE LIFE OF ANY FIBER, INCLUDING: IMPROPER HANDLING, CONTINUOUS LASING WITH THE FIBER TIP IN CONTACT WITH TISSUE, NEVER SUBJECT FIBER OPTICS TO SHARP BENDS IN HANDLING, USE, OR STORAGE, FIBER SHOULD NOT BE CLAMPED WITH FORCEPS OR OTHER SECURING INSTRUMENTS AS IT COULD RESULT IN FIBER DAMAGE OR BREAKAGE, EXTENDED LASING AT HIGH POWER, LASING WITH A CONTAMINATED OR DAMAGE PROXIMAL, POOR LASING BEAM ALIGNMENT OR FOCUS, ALWAYS KEEP CONNECTOR END DRY AND FREE OF CONTAMINANTS. BASED ON EVIDENCE PRESENTED, THE POTENTIAL CAUSE OF FIBER BREAKAGE IS DUE TO IMPROPER HANDLING OF THE LASER FIBER. ANY OF THE PRECAUTIONS LISTED IN THE IFU COULD CONTRIBUTE TO THIS EVENT. THE RISK ANALYSIS FOR THIS FAILURE MODE WAS REVIEWED, AND IT WAS DETERMINED THAT NO ADDITIONAL RISK MITIGATING ACTIVITY IS REQUIRED. THE FAILURE MODE WILL CONTINUE TO BE TRENDED AND MONITORED. 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 INFORMATION: D11: CONCOMITANT PRODUCTS: FLEXIBLE URETEROSCOPE, A TUORY-BORST, AN IRRIGATION SYSTEM, A COOK H30 ODYSSEY LASER SYSTEM. THE EVENT IS CURRENTLY UNDER INVESTIGATION. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON RECEIPT OF ADDITIONAL INFORMATION OR COMPLETION OF THE INVESTIGATION. 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 INFORMATION RECEIVED ON 12MAR2020: THE PROCEDURE WAS COMPLETED AFTER THE ISSUE BY USING ANOTHER LASER FIBER.
THERE IS NO NEW PATIENT OR EVENT INFORMATION TO REPORT.
ADDITIONAL INFORMATION RECEIVED ON 21FEB2020: THE PROCEDURE BEING PERFORMED AS A FLEXIBLE URETEROSCOPY IN THE KIDNEY. THE FIBER BROKE WHILE IN THE LOWER PART OF THE CALYX (IN THE KIDNEY), BUT THE SECTION OF THE DEVICE REMAINED INSIDE OF THE FLEXIBLE SCOPE. WHEN ASKED HOW THE PROCEDURE WAS COMPLETED, THE RESPONSE RECEIVED WAS "YES", BUT IT UNKNOWN HOW IT WAS COMPLETED. THERE WAS CONFIRMATION THAT THERE WERE NO ADVERSE EFFECTS DUE TO THE OCCURRENCE. NO ADDITIONAL PROCEDURES WERE REQUIRED DUE TO THIS OCCURRENCE.
(B)(6). PMA/510K #: K133788. THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE.
IT WAS REPORTED, DURING AN UNSPECIFIED PROCEDURE USING A COOK SINGLE-USE HOLMIUM LASER FIBER, THE FIBER BROKE IN THE "LOWER PART OF THE CHALICE." IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED. NO KNOWN ADVERSE EFFECTS HAVE BEEN REPORTED DUE TO THE ALLEGED MALFUNCTION. ADDITIONAL PATIENT AND EVENT DETAILS HAVE BEEN REQUESTED. A FOLLOW-UP REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION REQUESTED IS RECEIVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 169110 | COOK SINGLE-USE HOLMIUM LASER FIBER | GEX LASER INSTRUMENT, SURGICAL | GEX | COOK INC | G25293 | 9748823 | 00827002252936 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |