EVIS EXERA II DUODENOVIDEOSCOPE
Report
- Report Number
- 9610595-2025-36819
- Event Type
- Injury
- Date Received
- December 4, 2025
- Date of Event
- May 7, 2020
- Report Date
- December 26, 2025
- Manufacturer
- AIZU OLYMPUS CO., LTD.
- Product Code
- FDT
- PMA / PMN Number
- K143153
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE APPROVED FINAL INVESTIGATION. THE DEVICE HAS NOT BEEN RETURNED TO OLYMPUS FOR EVALUATION. BASED ON THE RESULTS OF THE INVESTIGATION, THE RELATIONSHIP BETWEEN THE DEVICE AND THE ADVERSE EVENT CANNOT BE CONFIRMED. THERE IS NO EVIDENCE OF AN OLYMPUS DEVICE MALFUNCTION. THEREFORE, THE ROOT CAUSE CANNOT BE DETERMINED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.
E1 - INITIAL REPORTER ESTABLISHMENT NAME: (B)(6). THE INVESTIGATION IS ONGOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETED OR IF ADDITIONAL INFORMATION BECOMES AVAILABLE.
NO ADDITIONAL INFORMATION RECEIVED FROM THE AUTHOR.
OLYMPUS REVIEWED THE FOLLOWING LITERATURE TITLED ¿IMPACT OF A NOVEL OBLIQUE-TIP PAPILLOTOME FOR BILIARY CANNULATION DURING ERCP: A NONRANDOMIZED COARSENED EXACT MATCHING STUDY¿. BACKGROUND. WE DEVELOPED A NOVEL OBLIQUE-TIP PAPILLOTOME (OT-PAPILLOTOME) TO FACILITATE BILIARY CANNULATION DURING ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP). THIS STUDY WAS PERFORMED TO EVALUATE THE UTILITY OF THE OT-PAPILLOTOME FOR CONTRAST-GUIDED CANNULATION (CGC) AND WIRE-GUIDED CANNULATION (WGC) DURING ERCP, COMPARED WITH STANDARD CANNULATION BY WGC USING A STANDARD-TIP PAPILLOTOME (ST-PAPILLOTOME). METHODS. A PROSPECTIVE STUDY WAS PERFORMED AT TWO CENTERS. CGC WITH THE OT-PAPILLOTOME (OT-CGC GROUP) WAS PERFORMED AT JIKEI UNIVERSITY HOSPITAL, WHILE WGC WAS DONE WITH THE OT-PAPILLOTOME AND ST-PAPILLOTOME (OT-WGC AND ST-WGC GROUPS, RESPECTIVELY) AT THE UNIVERSITY OF MALAYA MEDICAL CENTRE. THE RESULTS OF THE OT-CGC AND OT-WGC GROUPS WERE COMPARED WITH THOSE OF THE ST-WGC GROUP AFTER PERFORMING COARSENED EXACT MATCHING (CEM) TO REDUCE BIAS DUE TO NONRANDOMIZED AND CENTER-BASED PATIENT ALLOCATION. RESULTS. EIGHTY PATIENTS WERE ENROLLED IN EACH OF THE OT-CGC, OT-WGC, AND ST-WGC GROUPS. AFTER CEM, THE SUCCESSFUL BILIARY CANNULATION RATE WAS SIGNIFICANTLY HIGHER IN THE OT-CGC AND OT-WGC GROUPS THAN IN THE ST-WGC GROUP, WHILE RESCUE CANNULATION WAS REDUCED. THE MEAN NUMBER OF UNINTENDED PANCREATIC ACCESS EVENTS IN THE OT-WGC AND OT-CGC GROUPS WAS SIMILAR TO THE ST-WGC GROUP. HOWEVER, IT WAS SIGNIFICANTLY LOWER IN THE OT-WGC GROUP THAN IN THE OT-CGC GROUP. MULTIVARIATE ANALYSIS REVEALED THAT THE OT-PAPILLOTOME WAS INDEPENDENTLY ASSOCIATED WITH LESS FREQUENT RESCUE CANNULATION AND A HIGHER SUCCESSFUL BILIARY CANNULATION RATE. CONCLUSIONS. ALTHOUGH USE OF THE OT-PAPILLOTOME IN BILIARY CANNULATION DID NOT REDUCE UNINTENDED PANCREATIC ACCESS EVENTS OR PEP COMPARED TO THE ST-PAPILLOTOME, THE OT-PAPILLOTOME INCREASED THE SUCCESSFUL BILIARY CANNULATION RATE, WHILE REDUCING THE FREQUENCY OF RESCUE CANNULATION PROCEDURES. COMBINING THE OT-PAPILLOTOME WITH WGC MIGHT BE THE BEST CANNULATION TECHNIQUE FOR MINIMIZING UNINTENDED PANCREATIC ACCESS. TYPE OF ADVERSE EVENTS/NUMBER OF PATIENTS POST-ERCP PANCREATITIS (PEP) (13 PATIENT). THERE WAS NO ALLEGATION OF DEVICE MALFUNCTION IDENTIFIED IN THE ARTICLE. THIS REPORT IS 2 OF 4.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 130756 | EVIS EXERA II DUODENOVIDEOSCOPE | DUODENOVIDEOSCOPE | FDT | AIZU OLYMPUS CO., LTD. | TJF-Q180V |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | KD-V411M-0730 SINGLE USE 3-LUMEN SPHINCTEROTOME V |