COOK® SINGLE-USE HOLMIUM LASER FIBER
Report
- Report Number
- 1820334-2022-01694
- Event Type
- Injury
- Date Received
- November 4, 2022
- Date of Event
- September 14, 2022
- Report Date
- February 7, 2023
- Manufacturer
- COOK INC
- Product Code
- GEX
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
PMA/510(K) #- K163197 OR K133788 . 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, 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.
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, 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.
. EVENT DESCRIPTION: AS REPORTED, DURING A URETEROSCOPY WITH STENT REMOVAL AND LASER LITHOTRIPSY, A FOREIGN OBJECT RESEMBLING THE SEPARATED TIP OF AN UNKNOWN COOK HOLMIUM LASER FIBER WAS FOUND IN THE CALYX OF THE PATIENT'S LEFT KIDNEY. THE TIP WAS DISCOVERED WHEN RETRIEVING STONE FRAGMENTS FROM THE KIDNEY USING AN NGAGE STONE EXTRACTOR BASKET. THE PATIENT UNDERWENT A PREVIOUS LITHOTRIPSY PROCEDURE (B)(6) 2022 DURING WHICH THE LASER FIBER LIKELY SEPARATED. NO LASER FIBER HAD YET BEEN USED DURING THE LATTER PROCEDURE WHEN THE DEVICE TIP WAS RETRIEVED. NO ADVERSE EFFECTS TO THE PATIENT HAVE BEEN REPORTED. INVESTIGATION - EVALUATION REVIEWS OF INSTRUCTIONS FOR USE (IFU) AND QUALITY CONTROL PROCEDURES 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. THERE IS NO EVIDENCE TO SUGGEST THE PRODUCT WAS NOT MADE TO SPECIFICATIONS. COOK LASER FIBERS ARE 100% INSPECTED TO ASSURE NO BREAKS ARE PRESENT ALONG THE FIBER LENGTH AND THE GREEN OUTPUT FROM END OF FIBER IS PRESENT. A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE COMPLETED DUE TO LACK OF LOT INFORMATION FROM THE USER FACILITY. A REVIEW OF COMPLAINT HISTORY RECORDS COULD NOT BE COMPLETED DUE TO LACK OF LOT INFORMATION FROM THE USER FACILITY. THE INSTRUCTIONS FOR USE (IFU) PROVIDES THE FOLLOWING INFORMATION TO THE USER RELATED TO THE REPORTED FAILURE MODE: WARNINGS DO NOT BEND FIBER AT SHARP ANGLES. IF VISIBLE LIGHT (AIMING BEAM) CAN BE SEEN LEAKING FROM THE FIBER, FIBER FAILURE MAY RESULT WHEN THERAPEUTIC ENERGY IS APPLIED AS THE FIBER IS DEFLECTED BEYOND THE OPTICAL LIMITS OF TOTAL INTERNAL REFLECTION. FIBER SHOULD NOT BE CLAMPED WITH FORCEPS OR OTHER SECURING INSTRUMENTS AS IT COULD RESULT IN FIBER DAMAGE OR BREAKAGE. PRECAUTIONS A NUMBER OF DIFFERENT FACTORS AFFECT THE LIFE OF ANY PARTICULAR FIBER, INCLUDING: EXTENDED LASING AT HIGH POWER CONTINUOUS LASING WITH THE FIBER TIP IN CONTACT WITH TISSUE LASING WITH A CONTAMINATED OR DAMAGED PROXIMAL END IMPROPER HANDLING POOR LASER BEAM ALIGNMENT OR FOCUS NEVER SUBJECT FIBEROPTICS TO SHARP BENDS IN HANDLING, USE, OR STORAGE. ALWAYS KEEP CONNECTOR-END DRY AND FREE FROM CONTAMINANTS. DISCARD ANY FIBEROPTIC ASSEMBLY THAT IS CRACKED OR BROKEN, OR DOES NOT MEET MINIMUM TRANSMISSION STANDARDS. DO NOT EXCEED RECOMMENDED POWER LIMITS. HOW SUPPLIED UPON REMOVAL FROM PACKAGE, INSPECT THE PRODUCT TO ENSURE NO DAMAGE HAS OCCURRED. BASED ON THE AVAILABLE INFORMATION, A DEFINITIVE CAUSE OF THE LASER FIBER TIP BREAKAGE COULD NOT BE DETERMINED. IT IS POSSIBLE GENERAL DEVICE WEAR DURING USE CAN CAUSE THE TIP OF THE LASER FIBER DEVICE TO SEPARATE. DEVICE WEARING IS OFTEN DUE TO BEING A ¿CONTACT LASER FIBER¿. THE TIP OF THE LASER (FIBER CORE) REQUIRES THE DEVICE TO BE DIRECTLY AGAINST THE RENAL STONE (CALCULI), WHICH IS TYPICALLY HARD. THE VIBRATIONS AND THERMAL ENERGY CAUSED BY THE FIRING OF THE LASER WEARS DOWN THE FIBER AS IT FRAGMENTATES THE STONE. PER THE QUALITY ENGINEERING 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.
AS REPORTED, DURING A URETEROSCOPY WITH STENT REMOVAL AND LASER LITHOTRIPSY, A FOREIGN OBJECT RESEMBLING THE SEPARATED TIP OF AN UNKNOWN COOK HOLMIUM LASER FIBER WAS FOUND IN THE CALYX OF THE PATIENT'S LEFT KIDNEY. THE TIP WAS DISCOVERED WHEN RETRIEVING STONE FRAGMENTS FROM THE KIDNEY USING AN NGAGE STONE EXTRACTOR BASKET. THE PATIENT UNDERWENT A PREVIOUS LITHOTRIPSY PROCEDURE 14SEP2022 DURING WHICH THE LASER FIBER LIKELY SEPARATED. NO LASER FIBER HAD YET BEEN USED DURING THE LATTER PROCEDURE WHEN THE DEVICE TIP WAS RETRIEVED. NO ADVERSE EFFECTS TO THE PATIENT HAVE BEEN REPORTED.
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 |
|---|---|---|---|---|---|---|---|
| 2377899 | COOK® SINGLE-USE HOLMIUM LASER FIBER | GEX LASER INSTRUMENT, SURGICAL | GEX | COOK INC | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | Required Intervention |