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 Bowel Perforation (2668); Pancreatitis (4481)

Event Date 10/04/2023

Event Type  Injury  

Manufacturer Narrative

Since the literature described "olympus sifh290s", olympus selected "sif-h290s" as a representative product.The suspect device has not been returned to olympus for evaluation.The investigation is in process.The literature article is attached for additional information.Once the investigation has been completed, a supplemental report will be submitted with device evaluation results.

Event Description

Olympus reviewed the following literature titled "examination of the results of balloon endoscopic retrograde cholangiopancreatography (ercp) for common bile duct stones and intrahepatic stones in postoperative intestinal reconstruction cases at our hospital".The purpose was to examine the treatment outcomes and complications of balloon endoscopic retrograde cholangiopancreatography (baercp) with use of evis lucera elite small intestinal videoscope, sifh290s for common bile duct stones and intrahepatic stones in postoperative intestinal reconstruction cases at their hospital, dividing them into asymptomatic and symptomatic cases.53 patients with common bile duct and intrahepatic stones who underwent baercp using a short-type single-balloon small bowel endoscope for postoperative reconstructed intestinal tract from october 2016 to november 2022, they divided the first ercp cases after admission into 19 (14) asymptomatic cases and 34 (31) symptomatic cases.Ercp results: asymptomatic cases: reach rate: 73% and the median time to reach was 22.5 minutes.Symptomatic cases: reach rate: 88% and 31 minutes.There was no significant difference in the rate (42% vs 70%, p=0.0775).Post-ercp pancreatitis was observed in 1 asymptomatic case and 4 in symptomatic cases (p=0.643), and intestinal perforation was observed in 2 asymptomatic cases (p=0.124).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 and to provide additional information received from the author (b)(4).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.In addition, from the clinical/medical evaluation and risk assessment, it is possible that the reported event is an accident, or a complication associated with a procedure using the subject device.Therefore, the root cause cannot be determined.Olympus will continue to monitor field performance for this device.

Event Description

Additional information received from the author: no olympus device cause or contribute to any of the patient adverse events.No olympus device malfunction during any procedure.

• 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: 18187556
• MDR Text Key: 328741299
• Report Number: 9610595-2023-17868
• 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: 12/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2023
• 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: 11/30/2023
• 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
• Patient Outcome(s): Other