EVIS LUCERA ELITE DUODENOVIDEOSCOPE
Report
- Report Number
- 9610595-2023-00391
- Event Type
- Malfunction
- Date Received
- January 9, 2023
- Date of Event
- July 26, 2021
- Report Date
- February 3, 2023
- Manufacturer
- AIZU OLYMPUS CO., LTD.
- Product Code
- FDT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- NURSE
- Health Professional
- Yes
Narratives
THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE THE ADDITIONAL LEGAL MANUFACTURER'S (LM) FINDING AS FOLLOWS: A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO DEVIATIONS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. IT HAS BEEN OVER 3 YEARS SINCE THE SUBJECT DEVICE WAS MANUFACTURED. THIS SUPPLEMENTAL REPORT INCLUDES A CORRECTION TO D8, G2, AND H6 (INVESTIGATION FINDINGS). INFORMATION ADDED TO D8, G2, AND H6 (INVESTIGATION FINDINGS) THAT WAS INADVERTENTLY NOT INCLUDED ON THE INITIAL MEDWATCH. IN ADDITION, BASED ON THE ADDITIONAL LM FINDINGS, NEW INFORMATION ADDED TO H4 AND H6 (TYPE OF INVESTIGATION).
THE TJF-Q290V (SUBJECT DEVICE) AND THE MAJ-2315 (SINGLE USE DISTAL COVER) WERE NOT RETURNED TO OLYMPUS FOR EVALUATION. AN OLYMPUS SERVICE REPRESENTATIVE PROVIDED THE FOLLOWING INFORMATION: IT WAS UNCLEAR IF THE USER HAD ATTACHED THE DISTAL COVER TO THE ENDOSCOPE AND THEN PULLED OR TWISTED THE DISTAL COVER TO SEE IF IT COULD COME OFF. FURTHERMORE, IT WAS UNCLEAR WHETHER THE DISTAL COVER WAS CHECKED FOR DAMAGE AFTER IT WAS ATTACHED TO THE ENDOSCOPE. THE USER CONFIRMED THEY OCCASIONALLY USED AN ANTI-FOG AGENT, ALTHOUGH IT WAS NOT CLEAR IF AN ANTI-FOG AGENT WAS USED DURING THE REPORTED EVENT. IT WAS ALSO UNKNOWN IF THE DISTAL COVER WAS DAMAGED. OLYMPUS MEDICAL SYSTEMS CORPORATION (OMSC) USED A REPRESENTATIVE SAMPLE OF THE DISTAL COVER MAJ-2315 OF LOT NUMBER H0729 AND CONFIRMED THAT IF THE DISTAL COVER WAS NOT DAMAGED AND WAS NORMALLY ATTACHED TO THE ENDOSCOPE, IT WOULD NOT COME OFF THE ENDOSCOPE UNLESS THE DISTAL COVER WAS DAMAGED. THE EXACT CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED. HOWEVER, BASED ON THE INFORMATION PROVIDED, THE DISTAL COVER MAJ-2315 FALLING OFF THE ENDOSCOPE MAY HAVE BEEN CAUSED BY THE FOLLOWING CAUSES: -THE DISTAL COVER WAS DAMAGED BY A CHEMICAL ATTACK CAUSED BY THE ANTI-FOG AGENT ADHERING, WHICH MADE IT EASIER FOR THE DISTAL COVER TO COME OFF THE ENDOSCOPE. -DUE TO INSUFFICIENT ATTACHMENT OF THE DISTAL COVER TO THE ENDOSCOPE, THE DISTAL COVER WAS EASILY REMOVED FROM THE ENDOSCOPE. -THE DISTAL COVER WAS DAMAGED BY PUSHING THE DISTAL COVER DIAGONALLY WHEN IT WAS ATTACHED TO THE ENDOSCOPE AND THE DISTAL COVER WAS EASILY REMOVED FROM THE ENDOSCOPE. THE DEVICE'S OPERATION MANUAL PROVIDES THE FOLLOWING REGARDING THE USE OF ANTI-FOGGING AGENTS, WHICH CAN HELP TO PREVENT THE REPORTED ISSUE: "DO NOT APPLY ANTI-FOGGING PRODUCTS, OLIVE OIL, OR PRODUCTS CONTAINING PETROLEUM-BASED SUBSTANCES (E.G., VASELINE®) TO THE SINGLE USE DISTAL COVER OR THE ENDOSCOPE." OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.
OLYMPUS MEDICAL SYSTEMS CORPORATION (OMSC) WAS INFORMED BY THE USER THAT DURING AN UNSPECIFIED PROCEDURE, WHEN THE USER WITHDREW THE TJF-Q290V (SUBJECT DEVICE) FROM THE PATIENT, THE SINGLE USE DISTAL COVER (MAJ-2315) CAME OFF THE ENDOSCOPE AND FELL INTO THE PATIENT'S BODY. THE USER COMPLETED THE PROCEDURE WITH THE SUBJECT DEVICE. THERE WAS NO REPORT OF PATIENT INJURY OR HARM ASSOCIATED WITH THE EVENT. THIS REPORT IS RELATED TO COMPLAINT NUMBER (B)(4), WHICH WAS DOCUMENTED FOR THE MAJ-2315, AND REPORTED UNDER MEDWATCH NUMBER 8010047-2021-10307.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2304335 | EVIS LUCERA ELITE DUODENOVIDEOSCOPE | DUODENOVIDEOSCOPE | FDT | AIZU OLYMPUS CO., LTD. | TJF-Q290V |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | MAJ-2315 SINGLE USE DISTAL COVER |