MAUDE Adverse Event Report: AIZU OLYMPUS CO., LTD. EVIS LUCERA DUODENOVIDEOSCOPE

Model Number JF-260V

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

Patient Problem Pancreatitis (4481)

Event Date 10/29/2022

Event Type  Injury  

Manufacturer Narrative

The suspect device has not been returned to olympus.The investigation is in process.A supplemental report will be submitted upon completion of the investigation or if additional information is received.The literature is attached for additional information.

Event Description

Olympus reviewed the following literature titled "the usefulness of peroral cholangioscopy for intrahepatic stones." literature summary: this single-center retrospective study examined the results of transpapillary treatment of intrahepatic stones.A total of 26 patients were included.Complete stone removal (csr) was achieved in 92% (24/26) of cases; csr was not achieved in two cases.One case was an intrahepatic stone found incidentally and judged unnecessary to treat.The other case was after a bile duct resection for congenital biliary dilatation, and the double-balloon endoscope could not reach the anastomosis site.The median procedure time for the first session was 97 (27¿220) minutes, whereas that of the ehl under pocs group was 121 (43¿213) minutes and that of the fluoroscopic guidance group was 77 (27¿220) minutes, indicating that the ehl under pocs group had a significantly longer procedure time (p = 0.0195, mann¿whitney u test).In conclusion, endoscopic treatment for intrahepatic stones should be performed at established centers, because specialized devices such as a cholangioscope may be required and cholangitis may increase.Cholangitis developed in six (24%) and pancreatitis in three (12%) cases after the first session; however, all cases were mild and could be treated conservatively including antibiotic treatment.Although the incidence of cholangitis was high, there were no differences in complication rates between patients with and without ehl under pocs (p = 1, chi square test).Type of adverse events/number of patients: pancreatitis - 3 patients; cholangitis - 6 patients.This literature article requires 4 reports.The related patient identifiers are as follows: (b)(6): tjf-q290v duodenovideoscope; (b)(6): jf-260v duodenovideoscope; (b)(6): cf-hq290zi colonovideoscope; (b)(6): pr-110q-1 catheter.This medical device report is for patient identifier (b)(6).There is no report of any olympus device malfunction in any procedure described in this study.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.The device history record was unable to be reviewed for this device since the serial and/or lot number was not provided.However, olympus only releases products to market that meet all manufacturing specifications and final product release criteria.Based on the results of the investigation, the relationship between the device and the adverse event cannot be confirmed.There was no complaint reported on the subject device.There is no evidence of an olympus device malfunction.Therefore, the root cause cannot be determined.This supplemental report includes additional information received from the author.B5 updated accordingly.Also, a correction was made to g2 to provide information that was inadvertently not included in the initial medwatch.Olympus will continue to monitor field performance for this device.

Event Description

The following information was received from the author: the adverse events described in the article were not caused by an olympus device.Also, there were no reports of an olympus device malfunction.

• Brand Name: EVIS LUCERA DUODENOVIDEOSCOPE
• Type of Device: DUODENOVIDEOSCOPE
• Manufacturer (Section D): AIZU OLYMPUS CO., LTD.; 3-1-1 niiderakita; aizuwakamatsu-shi, fukushima 965-8 520; JA 965-8520
• Manufacturer (Section G): AIZU OLYMPUS CO., LTD.; 3-1-1 niiderakita; aizuwakamatsu-shi, fukushima
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 17481484
• MDR Text Key: 320662477
• Report Number: 9610595-2023-11327
• Device Sequence Number: 1
• Product Code: FDT
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Literature,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 07/10/2023
• Initial Date FDA Received: 08/08/2023
• Supplement Dates Manufacturer Received: 09/14/2023
• Supplement Dates FDA Received: 09/22/2023
• 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
• Treatment: CF-HQ290ZI COLONOVIDEOSCOPE; PR-110Q-1 CATHETER
• Patient Outcome(s): Required Intervention