MAUDE Adverse Event Report: SHIRAKAWA OLYMPUS CO., LTD. EVIS LUCERA ULTRASOUND GASTROVIDEOSCOPE

Model Number GF-UCT260

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

Patient Problems Perforation (2001); Unspecified Hepatic or Biliary Problem (4493)

Event Date 05/18/2022

Event Type  Injury  

Manufacturer Narrative

The suspect device has not been returned to olympus for evaluation.The investigation is in process.The literature article is attached for additional information.The investigation is ongoing.If additional information becomes available, this report will be supplemented accordingly.

Event Description

Olympus reviewed the following literature titled, "long-term outcomes of endoscopic double stenting using an anti-reflux metal stent for combined malignant biliary and duodenal obstruction".Purpose: to evaluate long-term outcomes of endoscopic double stenting using anti-reflux metal stents (arms) for combined malignant biliary and duodenal obstruction.Methods: consecutive patients with advanced pancreatic cancer who received endoscopic double stenting with self-expandable metal stents (sems) for combined malignant biliary and duodenal obstruction at our institution between july 2014 and march 2021 were evaluated.Patients were divided into the arms group, endoscopic ultrasound-guided hepaticogastrostomy (eus-hgs) group, and covered metal stent-transpapillary (cms-transpapillary) group.A duckbilltype metal stent was used in all arms cases.Results: thirty-eight patients were enrolled: arms group (n = 16), eus-hgs group (n = 13), and cms-transpapillary group (n = 9).Overall survival among three groups were not significantly different.Recurrent biliary obstruction (rbo) rates of the arms, eus-hgs, and cms-transpapillary groups were 12.5%, 61.5%, and 88.9% (p<.01) and median time to recurrent biliary obstructions (trbos) were not reached, 125days, and 7days (p<.01).Median trbos of armscholedochoduodenostomy and arms-transpapillary were not statistically different.Major causes of rbo were stent occlusion and symptomatic stent migration in the arms group, hyperplasia in the eus-hgs group, and non-occlusion cholangitis in the cms-transpapillary group.Conclusions: endoscopic double stenting with arms might be an option for combined malignant biliary and duodenal obstruction.Type of adverse events/number of patients perforation(eus-hgs group) n=1 recurrent biliary obstruction n=8 this literature article requires 4 reports.The related patient identifiers are as follows: 1.(b)(6).This medwatch 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 and to provide additional information received from the author.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.

Event Description

Additional information received from the author confirmed there was no particular causal relationship between the device and the adverse event.

• Brand Name: EVIS LUCERA ULTRASOUND GASTROVIDEOSCOPE
• Type of Device: ULTRASOUND GASTROVIDEOSCOPE
• Manufacturer (Section D): SHIRAKAWA OLYMPUS CO., LTD.; 3-1 okamiyama; odakura, nishigo-mura,; nishishirakawa-gun, fukushima 961-8 061; JA 961-8061
• Manufacturer (Section G): SHIRAKAWA OLYMPUS CO., LTD.; 3-1 okamiyama; odakura, nishigo-mura,; nishishirakawa-gun, fukushima
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 16595485
• MDR Text Key: 311827842
• Report Number: 3002808148-2023-02851
• Device Sequence Number: 1
• Product Code: ODG
• 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: 05/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: GF-UCT260
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/12/2023
• 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: NON-OLYMPUS: METAL STENT.
• Patient Outcome(s): Other