EVIS EXERA III XENON LIGHT SOURCE
Report
- Report Number
- 8010047-2021-15595
- Event Type
- Malfunction
- Date Received
- December 6, 2021
- Date of Event
- November 8, 2021
- Report Date
- February 22, 2022
- Manufacturer
- OLYMPUS MEDICAL SYSTEMS CORP.
- Product Code
- NWB
- UDI-DI
- 04953170298868
- PMA / PMN Number
- CLASS2-EXMPT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
THE SUSPECT DEVICE WAS RETURNED TO OLYMPUS AND EVALUATED. THE REPORTED PROBLEM COULD NOT BE CONFIRMED, HOWEVER, THE XENON LAMP WAS NOTED TO HAVE AN IGNITION PROBLEM WHEN COLD. IN ADDITION, IT WAS FOUND THAT THE LAMP FAILED AND WAS BLINKING, MAKING TISSUE INDISTINGUISHABLE. PUMP CONTAMINATION WAS NOTED AS WELL. THE INVESTIGATION IS ONGOING AND THE ROOT CAUSE OF THE REPORTED EVENT CANNOT BE DETERMINED AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE SUPPLEMENTED ACCORDINGLY.
THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE LEGAL MANUFACTURER'S FINAL INVESTIGATION. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO DEVIATIONS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. BASED ON THE RESULTS OF THE LEGAL MANUFACTURER'S INVESTIGATION, THE ERROR OCCURRED EXCLUSIVELY WHEN THE LAMP WAS COLD BUT DID NOT OCCUR WITH THE INSPECTION WORKSHOP'S OWN XENON LAMP. THE DEVICE WAS FOUND TO BE VERY DUSTY AND HAD TO BE CLEANED. IT WAS ASSUMED THAT WEAR AND TEAR DAMAGE CONTRIBUTED TO THE EVENT AS CAUSED BY CUSTOMER MISHANDLING AND INCREASING USE/TIME. FURTHER INCOMING INSPECTION FINDINGS: THE FRONT COVER (PLASTIC) IS DAMAGED; THE POWER SWITCH IS BROKEN; THE LIGHT GUIDE TUBE OF THE SOCKET IS BROKEN. THE INSTRUCTION MANUAL IDENTIFIES THE FOLLOWING RELATED VERBIAGE WHICH COULD HELP PREVENT THE ABOVE PHENOMENON: ¿AVOID USING THE LIGHT SOURCE IN A DUSTY ENVIRONMENT. THIS MAY DAMAGE THE LIGHT SOURCE. CLEAN AND VACUUM DUST THE VENTILATION GRILLS USING A VACUUM CLEANER. OTHERWISE, THE LIGHT SOURCE MAY BREAK DOWN AND GETS DAMAGED FROM OVERHEATING.¿ OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.
THE SUSPECT DEVICE WAS RETURNED TO OLYMPUS AND EVALUATED. THE REPORTED PROBLEM COULD NOT BE CONFIRMED, HOWEVER, THE XENON LAMP WAS NOTED TO HAVE AN IGNITION PROBLEM WHEN COLD. IN ADDITION, IT WAS FOUND THAT THE LAMP FAILED AND WAS BLINKING, MAKING TISSUE INDISTINGUISHABLE. PUMP CONTAMINATION WAS NOTED AS WELL. THE INVESTIGATION IS ONGOING AND THE ROOT CAUSE OF THE REPORTED EVENT CANNOT BE DETERMINED AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE SUPPLEMENTED ACCORDINGLY.
THIS SUPPLEMENTAL REPORT IS SUBMITTED TO PROVIDE ADDITIONAL EVENT RELATED INFORMATION.
A USER FACILITY REPORTED TO OLYMPUS THAT THE DEVICE SWITCHED TO THE SPARE LAMP. THERE WAS NO PATIENT INJURY, ASSOCIATED WITH THE PROBLEM, REPORTED TO OLYMPUS.
A USER FACILITY REPORTED TO OLYMPUS THAT THE DEVICE SWITCHED TO THE SPARE LAMP. THERE WAS NO PATIENT INJURY, ASSOCIATED WITH THE PROBLEM, REPORTED TO OLYMPUS.
THE PROBLEM, AS REPORTED TO OLYMPUS, OCCURRED DURING A PROCEDURE. THE INTENDED PROCEDURE WAS COMPLETED USING THE SAME DEVICE. THERE WAS NO PATIENT INJURY THAT OCCURRED, ASSOCIATED WITH THE EVENT. THIS IS REPORT #1 OF 2 DUE TO MULTIPLE EVENTS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1837104 | EVIS EXERA III XENON LIGHT SOURCE | XENON LIGHT SOURCE | NWB | OLYMPUS MEDICAL SYSTEMS CORP. | CLV-190 | 04953170298868 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |