MAUDE Adverse Event Report: AIZU OLYMPUS CO., LTD. EVIS LUCERA ELITE SMALL INTESTINAL VIDEOSCOPE; SMALL INTESTINAL VIDEOSCOPE

Model Number SIF-H290S

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

Patient Problems Hemorrhage/Bleeding (1888); Laceration(s) (1946); Bowel Perforation (2668); Pancreatitis (4481)

Event Date 09/13/2023

Event Type  Injury  

Manufacturer Narrative

The device has not been returned to olympus for evaluation.The literature article is attached for additional information.The investigation is ongoing, and a supplemental report will be submitted upon completion of the investigation or if any additional information is provided.

Event Description

Olympus reviewed the following literature titled "dp-468 transmammary endoscopic treatment of bile duct stones in the reconstructed intestinal tract after surgery." we have been performing endoscopic bile duct stone removal using a short single-balloon endoscope (short-sbe) for the treatment of bile duct stones in patients with reconstructed intestinal tracts after surgery.We evaluate the efficacy and safety of this treatment.Type of adverse events/number of patients.Pancreatitis (5).Perforation (3).Bleeding (1).Laceration (1).There were five patients that developed pancreatitis in which 3 were mild and 2 were severe pancreatitis.One of the severe pancreatitis patients was hospitalized due to difficulty to go home.The bile duct was penetrated in one of three perforation patients but recovered with conservative treatment.Another patient was sent to surgical treatment.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 events 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.Olympus will continue to monitor field performance for this device.

• Brand Name: EVIS LUCERA ELITE SMALL INTESTINAL VIDEOSCOPE
• Type of Device: SMALL INTESTINAL VIDEOSCOPE
• 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: 18091996
• MDR Text Key: 327622657
• Report Number: 9610595-2023-16691
• Device Sequence Number: 1
• Product Code: FDA
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Study,Literature,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/24/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: SIF-H290S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/24/2024
• 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): Required Intervention; Hospitalization