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); Pancreatitis (4481)

Event Date 01/18/2024

Event Type  Injury  

Manufacturer Narrative

This report is related to the following linked patient identifiers: ¿ (b)(6).Should additional relevant information become available, a supplemental report will be submitted¿.

Event Description

Olympus reviewed the following literature titled "a comparison of diagnostic utility of new endoscopic scraper combined cell block method and conventional brush catheter for biliary tract cancer".Literature summary background/aims: the sensitivities of endoscopic trans-papillary pathologic diagnosis of biliary tract cancer (btc) are unsatisfactory.Recently, the diagnostic utility of the endoscopic scraper device, trefle for biliary stricture has been reported.The trefle can be guided to the target biliary stricture over the guidewire and is as easy to use as the conventional brush catheter (cbc).This study evaluated the efficacy and safety of trefle-assisted tissue acquisition combined cell block method and cbc cytology for biliary strictures due to btcs.Methods: we retrospectively reviewed consecutive patients with biliary strictures in whom cbc cytology or trefle-assisted tissue acquisition under endoscopic retrograde cholangiopancreatography was performed for suspected btcs from january 2015 to june 2022 at our institution.Results: 173 patients (cbc group; n = 55, trefle group; n = 118) were enrolled in this study.The sensitivity, specificity, and accuracy of cbc cytology for btc were 68.3%/100%/76.4%.On the other hand, the sensitivity, specificity, and accuracy of trefle-assisted tissue acquisition for btc were 93.7%/95.7%/94.1%, showing superior sensitivity (p < 0.001) and accuracy (p = 0.002) compared to that of cbc.Post-ercp pancreatitis (pep) occurred in 11 (20.0%) in the cbc group and 13 (11%) in the trefle group.The incidence of pep tended to be higher in both groups, but the difference between the two groups was not significant.The pep was considered severe in three (5.5%) patients in the cbc group and five (4.2%) in the trefle group.One case of post-est bleeding was observed in the cbc group but improved with endoscopic therapy.Conclusions: compared to cbc cytology, trefle-assisted tissue acquisition has superior diagnostic performance while maintaining procedural simplicity and is considered useful for diagnosing malignant biliary stricture.Type of adverse events/number of patients pancreatitis (32) bleeding (1).

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, a 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.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 965-8 520; JA 965-8520
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 18855763
• MDR Text Key: 337186367
• Report Number: 9610595-2024-04876
• 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
• Report Date: 03/07/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2024
• 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: 02/14/2024
• 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