EVIS EXERA LLL COLONOVIDEOSCOPE
Report
- Report Number
- 8010047-2021-17008
- Event Type
- Malfunction
- Date Received
- December 30, 2021
- Report Date
- March 10, 2022
- Manufacturer
- OLYMPUS MEDICAL SYSTEMS CORP.
- Product Code
- FDF
- UDI-DI
- 04953170305177
- PMA / PMN Number
- K131780
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
THE SUBJECT DEVICE WAS RECEIVED AND EVALUATED AT RRC (REGIONAL REPAIR CENTER) OLYMPUS (B)(4). DURING SERVICE INVESTIGATION, THE CUSTOMER SPECIFIED ISSUE OF "REMAINS OF CHEMICAL PRODUCT INSIDE CHANNEL" WAS NOT CONFIRMED, HOWEVER IT WAS DECIDED TO EXCHANGE THE FOLLOWING PARTS BELOW AS PREVENTIVE: THE FOLLOWING PARTS TO BE REPLACED ARE BELOW: NOZZLE UNIT, ALL CHANNEL, AIR WATER CYLINDER, SUCTION CYLINDER, CHANNEL MOUTHPIECE, AND KS MOUTHPIECE IN ADDITION, INSPECTION FOUND - A-RUBBER GLUING WORN OUT, - C-COVER SCRATCHED, CHIPPED LIGHT GUIDE AND KNOB PLAY AND LESS ANGULATIONS. INVESTIGATION IS ONGOING. THIS REPORT WILL BE SUPPLEMENTED ACCORDINGLY FOLLOWING INVESTIGATION.
THE SUBJECT DEVICE WAS RECEIVED AND EVALUATED AT RRC (REGIONAL REPAIR CENTER) OLYMPUS FRANCE. DURING SERVICE INVESTIGATION, THE CUSTOMER SPECIFIED ISSUE OF "REMAINS OF CHEMICAL PRODUCT INSIDE CHANNEL" WAS NOT CONFIRMED, HOWEVER IT WAS DECIDED TO EXCHANGE THE FOLLOWING PARTS BELOW AS PREVENTIVE: THE FOLLOWING PARTS TO BE REPLACED ARE BELOW: NOZZLE UNIT, ALL CHANNEL, AIR WATER CYLINDER, SUCTION CYLINDER, CHANNEL MOUTHPIECE, AND KS MOUTHPIECE IN ADDITION, INSPECTION FOUND - A-RUBBER GLUING WORN OUT, - C-COVER SCRATCHED, CHIPPED LIGHT GUIDE AND KNOB PLAY AND LESS ANGULATIONS. INVESTIGATION IS ONGOING. THIS REPORT WILL BE SUPPLEMENTED ACCORDINGLY FOLLOWING INVESTIGATION.
CORRECTION TO G2 TO ADD THE FOREIGN COUNTRY FRANCE. THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON RESULTS OF THE LEGAL MANUFACTURER'S FINAL INVESTIGATION. THE DEVICE WAS EVALUATED WHERE NO ABNORMALITIES WERE FOUND THAT COULD CAUSE A POTENTIAL ADVERSE EVENT. 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 INVESTIGATION, IT IS UNLIKELY THERE WAS A PROBLEM WITH THE USER'S HANDLING, REPROCESSING, FACILITY EQUIPMENT OR THE LIKE. AS THE EVENT COULD NOT BE CONFIRMED, THE ROOT CAUSE COULD NOT BE SPECIFIED. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.
AS REPORTED, THE CUSTOMER INFORMED ABOUT A DYSFUNCTION DURING A MAINTENANCE OPERATION OF GENERAL WATER SUPPLY DURING CDS PROCESS OF THIS ENDOSCOPE. CUSTOMER SUSPECTED PRESENCE OF LIQUID SILICONE IN ALL CHANNELS FOLLOWING A MAINTENANCE OPERATION OF THE WATER SYSTEM. THERE IS NO PATIENT INVOLVEMENT ASSOCIATED ON THIS REPORTED EVENT. NO USER INJURY REPORTED.
AS REPORTED, THE CUSTOMER INFORMED ABOUT A DYSFUNCTION DURING A MAINTENANCE OPERATION OF GENERAL WATER SUPPLY DURING CDS PROCESS OF THIS ENDOSCOPE. CUSTOMER SUSPECTED PRESENCE OF LIQUID SILICONE IN ALL CHANNELS FOLLOWING A MAINTENANCE OPERATION OF THE WATER SYSTEM. THERE IS NO PATIENT INVOLVEMENT ASSOCIATED ON THIS REPORTED EVENT. NO USER INJURY REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2014431 | EVIS EXERA LLL COLONOVIDEOSCOPE | COLONOVIDEOSCOPE | FDF | OLYMPUS MEDICAL SYSTEMS CORP. | CF-H190I | 04953170305177 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |