MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. EVIS LUCERA DUODENOVIDEOSCOPE

Model Number JF-260V

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hemorrhage/Bleeding (1888); Pancreatitis (4481)

Event Date 01/22/2022

Event Type  Injury  

Manufacturer Narrative

The device referenced in this report was not returned to olympus for evaluation.The definitive cause of the user's experience cannot be determined at this time.The investigation is ongoing.This report will be updated upon completion of the investigation or upon receipt of additional relevant information.

Event Description

It is reported in the literature titled "analysis of symptomatic recurrences of common bile ducts stones after endoscopic removal factors related to early or multiple recurrences," patients experienced adverse events after procedure using an olympus duodenovideoscope.Background: aim: early or multiple recurrences of symptomatic common bile duct (cbd) stones are troublesome late complications after endoscopic stone removal.We aimed to determine the factors related to early or multiple recurrences of cbd stones.Method: retrospective analysis of patients who underwent endoscopic cbd stone extraction in a single institute between january 2006 and december 2015.Patients were divided into 2 groups according to the number and interval of cbd stone recurrences: single versus multiple (=2) and early (<1.5 years) versus late (=1.5 years) recurrence.Results: after exclusion, 78 patients were enrolled and followed up for a median of 1974 (iqr: 938¿3239) days.Twenty-seven (34.6%) patients experienced multiple recurrences (=2 times), and 26 (33.3%) patients experienced early first recurrence (<1.5 years).In the multivariate analysis, cbd angulation was independently related to multiple cbd stone recurrence (or: 4.689, p=.016), and endoscopic papillary large balloon dilation was independently related to late first cbd stone recurrence (or: 3.783, p=.025).The mean cbd angles were more angulated with increasing instances of recurrence (0, 1, 2, 3, and =4 times) with corresponding values of 150.3°, 148.2°, 143.6°, 142.2°, and 126.7°, respectively (p=.011).The period between the initial treatment and first recurrence was significantly longer than the period between the first and second recurrence (p=.048).In conclusion, greater cbd angulation is associated with the increased number of cbd stone recurrence, and eplbd delays the recurrence of cbd stones after endoscopic cbd stone removal.For post-procedural complications, one patient had post-ercp bleeding, and 11 patients developed mild post-ercp pancreatitis.There is no report of olympus device malfunction in any procedure described ion this literature.

Manufacturer Narrative

This report is being updated to provide additional information reported by the author/physician and investigation findings.New information is reported in b5, h6, and h10.The devices referenced in this report were not returned to olympus for physical evaluation.The device history record (dhr) for the complaint devices could not be reviewed since the serial numbers were not provided.Olympus does not ship any device that does not meet all design and safety specifications.Conclusion: no malfunction of any olympus device was reported in any procedure described in this article.From the information reported, it is presumed that the causes of the reported events are not due to product defects, but the definitive cause could not be established.

Event Description

Additional information provided by the author/physician: no olympus device malfunctioned in any procedure described in this literature.We are unable to provide the serial numbers for the devices used.No olympus device caused or contributed to any of the adverse events experienced by the patients in this study.

• Brand Name: EVIS LUCERA DUODENOVIDEOSCOPE
• Type of Device: DUODENOVIDEOSCOPE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• Manufacturer Contact: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 14755880
• MDR Text Key: 295037228
• Report Number: 8010047-2022-10435
• Device Sequence Number: 1
• Product Code: FDT
• Combination Product (y/n): N
• Reporter Country Code: KS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Study,Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/21/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: JF-260V
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/14/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other