H30 HOLMIUM LASER 30 WATT HOLMIUM LASER
Report
- Report Number
- 1820334-2018-00225
- Event Type
- Malfunction
- Date Received
- February 8, 2018
- Date of Event
- January 9, 2018
- Report Date
- March 2, 2018
- Manufacturer
- COOK INC
- Product Code
- GEX
- Report Source
- Manufacturer report
- Reporter Location
- GB
- Reporter Occupation
- NURSE
Narratives
ADDITIONAL EVENT DETAILS PROVIDED.
INVESTIGATION ¿ EVALUATION: LASER GENERATORS ARE SERVICED IN THE FIELD, NO COMPLAINT DEVICE IS EXPECTED FOR RETURN. THE INVESTIGATION INCLUDES A REVIEW OF NOTES FROM FIELD SERVICE ACTIVITIES, COMPLAINT HISTORY, THE INSTRUCTIONS FOR USE, MANUFACTURING INSTRUCTIONS, QUALITY CONTROL DATA AND DEVICE SPECIFICATIONS. TROUBLESHOOTING WAS PERFORMED BY THE SERVICE TECHNICIAN ON THE H30 HOLMIUM LASER 30 WATT, SERIAL NUMBER (B)(4) AT THE USER FACILITY. SERVICE REPORTS DATED 10JAN2018 AND 19JAN2018 WERE RECEIVED FROM THE CAPITAL EQUIPMENT SPECIALIST CONFIRMING THE EMERGENCY STOP ISSUE AND INDICATING CAUSE OF THE ISSUE TO BE EXCESSIVE FORCE BREAKING THE BUTTON. THE DEVICE HAS BEEN REPAIRED. A REVIEW OF COMPLAINT HISTORY FOUND THREE OTHER COMPLAINTS ASSOCIATED WITH THE COMPLAINT DEVICE SERIAL NUMBER. THE ADDITIONAL COMPLAINTS ARE UNRELATED TO THE CURRENT COMPLAINT FAILURE MODE. BASED ON THE INVESTIGATION EVALUATION, THERE IS NO INDICATION THAT A DESIGN OR PROCESS RELATED FAILURE MODE CONTRIBUTED TO THIS EVENT. CURRENT CONTROLS FOR MANUFACTURING ARE IN PLACE TO ASSURE FUNCTIONALITY AND DEVICE INTEGRITY PRIOR TO SHIPPING. REVIEW OF PRODUCTION AND QUALITY DOCUMENTATION DID NOT OBSERVE ANY SPECIFIC ISSUES WITH CURRENT MANUFACTURING OR QUALITY CONTROLS THAT MAY HAVE CONTRIBUTED TO THIS INCIDENT. THE LIKELY ROOT CAUSE FOR THE EVENT IS PRODUCT USE OR HANDLING RELATED DUE TO EXCESSIVE PRESSURE USED ON THE EMERGENCY STOP BUTTON. PER THE QUALITY ENGINEERING RISK ASSESSMENT, NO FURTHER ACTION IS WARRANTED. COOK MEDICAL HAS NOTIFIED THE APPROPRIATE PERSONNEL AND WILL CONTINUE TO MONITOR THIS DEVICE VIA THE COMPLAINTS DATABASE FOR SIMILAR COMPLAINTS.
AT FIRST POINT OF CONTACT WE WERE INFORMED THAT THE CASE WAS ABANDONED BUT SUBSEQUENTLY FOUND OUT THE CASE WAS COMPLETED SUCCESSFULLY TO THE SATISFACTION OF THE SURGEON. CASE WAS COMPLETED, SURGEON MOVED THE LASER AWAY FROM THE OPERATING TABLE. IT WAS OBSERVED BY THE SURGEON THAT THE EMERGENCY STOP BUTTON WAS PUSHED IN AND ENGAGED. A MEMBER OF STAFF WAS CALLED OVER AND BOTH NOTED THAT THE BUTTON WOULD NOT MOVE EITHER BY ROTATING OR PULLING OUT (SAID IT WAS STIFF NOT FREELY MOVING). THE LASER WOULD NOT TURN ON AT THIS POINT. THEY USED A LASER FROM ANOTHER THEATRE TO COMPLETE TO OPERATING LIST.
(B)(4). PMA/510K # ¿ K130444. THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE.
IT WAS REPORTED THAT THE LASER MACHINE TURNED OFF MID PROCEDURE AND WOULD NOT POWER BACK ON. THE PATIENT WAS UNDER GENERAL ANESTHESIA. THERE WERE NO ERROR MESSAGES ON THE LASER SCREEN. THE DEVICE HAS BEEN REPAIRED AND THE ENGINEER FOUND THE EMERGENCY STOP BUTTON WAS SPINNING AROUND IN THE BARREL AND THE CLASPS FOR THE EMERGENCY BUTTON WERE SNAPPED OFF. THE FINAL OUTCOME FOR THE PATIENT AND THE PROCEDURE IS UNKNOWN. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED. REQUEST WERE MADE FOR ADDITIONAL INFORMATION REGARDING; FINAL OUTCOME FOR THE PATIENT AND THE PROCEDURE, A COPY OF THE SERVICE REPORT, AND WHAT PROCEDURE WAS BEING PERFORMED, HOWEVER, THE CUSTOMER HAS NOT PROVIDED ANY FURTHER INFORMATION AT THIS TIME.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 101820 | H30 HOLMIUM LASER 30 WATT HOLMIUM LASER | GEX LASER INSTRUMENT, SURGICAL | GEX | COOK INC |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other| R |