COOK SINGLE-USE HOLMIUM LASER FIBER
Report
- Report Number
- 1820334-2020-00412
- Event Type
- Malfunction
- Date Received
- February 21, 2020
- Date of Event
- February 13, 2020
- Report Date
- May 19, 2020
- Manufacturer
- COOK INC
- Product Code
- GEX
- UDI-DI
- 00827002252936
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GB
- Reporter Occupation
- OTHER
Narratives
ADDITIONAL INFORMATION: H6: METHOD CODE AND H10 - DEVICE WAS RETURNED AND INCLUDES EVALUATION OF RETURNED DEVICE. INVESTIGATION ¿ EVALUATION: VISUAL EXAMINATION CONFIRMED FIBER WAS RETURNED IN USED CONDITION AND SEPARATED INTO TWO SEGMENTS. THE DISTAL SEGMENT MEASURED 51.5CM WITH 4MM OF FIBER OPTICS PROTRUDING FROM THE DISTAL END; PROXIMAL SEGMENT MEASURED 247.4CM. TOTAL LENGTH OF RETURNED FIBER IS 298.9CM. POINT OF SEPARATION DISPLAYED BLACK CHARRED DEBRIS ON THE BLUE JACKET. JACKET APPEARED MELTED AND PULLED TO SEPARATION. BROKEN FIBER WAS VISIBLE ON BOTH SEVERED ENDS. NO DAMAGE WAS OBSERVED ON THE METAL PLUG. COOK HAS CONCLUDED THAT BASED ON EVIDENCE PRESENTED, POTENTIAL CAUSE OF FIBER BREAKAGE CAN BE RELATED TO IMPROPER HANDLING OF LASER FIBER AND ANY OF THE PRECAUTIONS LISTED IN THE IFU COULD CONTRIBUTE TO THIS EVENT. PER THE QUALITY ENGINEERING RISK ASSESSMENT, NO FURTHER ACTION IS WARRANTED. COOK WILL CONTINUE TO MONITOR THIS DEVICE VIA THE COMPLAINTS DATABASE 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.
INVESTIGATION ¿ EVALUATION. IT WAS REPORTED, THAT SHORTLY AFTER BEGINNING A LASER LITHOTRIPSY PROCEDURE, A COOK SINGLE-USE HOLMIUM LASER FIBER BROKE INTO TWO PIECES INSIDE OF THE URETEROSCOPE AND THE SURGEON NOTICED THE AIMING BEAM DISAPPEARED. THE BREAK OCCURRED WHILE THE FIBER WAS INSIDE THE SEMI-RIGID URETEROSCOPE. THE PROCEDURE WAS COMPLETED BY REPLACING WITH A NEW FIBER. NO SECTION OF THE DEVICE REMAINED INSIDE OF THE PATIENT'S BODY AND NO ADVERSE EVENT WAS REPORTED AS A RESULT OF REPORTED ISSUE. THERE WERE NUMEROUS REQUESTS MADE FOR DEVICE RETURN THAT WENT UNANSWERED. A DOCUMENT BASED INVESTIGATION WAS PERFORMED INCLUDING A REVIEW OF COMPLAINT HISTORY, DEVICE HISTORY RECORD, THE INSTRUCTIONS FOR USE, MANUFACTURING INSTRUCTIONS, AND QUALITY CONTROL DATA. 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 MADE OUT OF SPECIFICATION. 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. THE INSTRUCTIONS FOR USE (IFU), PROVIDES THE FOLLOWING INFORMATION TO THE USER RELATED TO THE REPORTED FAILURE MODE: 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. 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. REQUEST HAS BEEN SENT TO RETURN THE DEVICE TO COOK FACILITY FOR TECHNICAL EVALUATION AND NO DEVICE HAS BEEN RETURNED YET. THE INVESTIGATION WILL BE UPDATED AS NECESSARY IF THE DEVICE RETURN AND EVALUATION OF DEVICE. COOK HAS CONCLUDED THAT BASED ON EVIDENCE PRESENTED, POTENTIAL CAUSE OF FIBER BREAKAGE CAN BE RELATED TO IMPROPER HANDLING OF LASER FIBER AND ANY OF THE PRECAUTIONS LISTED IN THE IFU COULD CONTRIBUTE TO THIS EVENT. PER THE QUALITY ENGINEERING RISK ASSESSMENT, NO FURTHER ACTION IS WARRANTED. COOK MEDICAL WILL CONTINUE TO MONITOR THIS DEVICE VIA THE COMPLAINTS DATABASE 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.
NO NEW PATIENT OR EVENT INFORMATION TO REPORT.
NO NEW PATIENT OR EVENT INFORMATION TO REPORT.
CONCOMITANT MEDICAL PRODUCTS: CONCOMITANT DEVICES: SENSOR GUIDEWIRE 0.035, CATHETER 6FR, HOLMIUM LASER H30 RHAPSODY, SEMIRIGID URETEROSCOPE. POSTAL CODE: (B)(6). OCCUPATION: SISTER. 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 INITIALLY REPORTED BY THE CUSTOMER, DURING A STONE FRAGMENTATION FURS (FLEXIBLE AND RIGID URETEROSCOPY) PROCEDURE USING A COOK SINGLE-USE HOLMIUM LASER FIBER, THE FIBER BROKE IN TWO PIECES INSIDE OF THE URETEROSCOPE. THEY WERE ALERTED WHEN THE SURGEON LOST VISION OF THE AIMING BEAM. THE SCRUB NURSE REMOVED THE FIBER AND NOTED THE BREAK. AN ADVERSE INCIDENT REPORT WAS RECEIVED ON 19FEB2020 THAT PROVIDED THE FOLLOWING ADDITIONAL DETAILS. SHORTLY AFTER BEGINNING A LASER LITHOTRIPSY PROCEDURE THE SURGEON NOTICED THE AIMING BEAM DISAPPEARED. THE LASER WAS PUT ON STANDBY, THE FIBER WAS WITHDRAWN, AND IT WAS DISCOVERED TO BE BROKEN. THE BREAK OCCURRED WHILE THE FIBER WAS INSIDE THE SEMIRIGID URETEROSCOPE. THE PROCEDURE WAS COMPLETED BY REPLACING WITH A NEW FIBER. THERE WAS NO INJURY TO EQUIPMENT OR PERSONS. NO SECTION OF THE DEVICE REMAINED INSIDE OF THE PATIENT'S BODY. ACCORDING TO THE INITIAL REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 200576 | COOK SINGLE-USE HOLMIUM LASER FIBER | GEX LASER INSTRUMENT, SURGICAL | GEX | COOK INC | G25293 | 9824309 | 00827002252936 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 60 YR |