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

Model Number GF-UCT180

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

Patient Problem Insufficient Information (4580)

Event Date 08/08/2022

Event Type  Death  

Event Description

Olympus reviewed the following literature titled "eus-guided biliary drainage in patients with moderate¿severe cholangitis is safe and effective: a multi-center experience.".This is a retrospective review of a prospectively maintained endoscopy database to assess outcomes of endoscopic ultrasound-guided biliary drainage (eus-bd) in patients with moderate¿severe cholangitis.A total of 263 cases of eus-bd were reviewed.Of the 49 patients (23 male; 46.9%) presenting with moderate/severe cholangitis, 23 (46.9%) had severe cholangitis.Clinical success with improvement of cholangitis, on the overall cohort, was 91.7% (44/48).Effective biliary drainage (ebd) defined as reduction in bilirubin by more than 50% of baseline at 2 weeks, and/or bilirubin<3.0 mg/dl at 4 weeks.Ebd, on the overall cohort, was noted in 85.4% (41/48) cases.Adverse events in the form of mostly bleeding and bile leak were noted in 5 cases (10.2%) but managed conservatively.Distal obstruction exhibited significantly better clinical success (100% vs.78.9%; p=0.02) than hilar obstruction.In conclusion, in case of failed/non-feasible ercp, eus-bd can be a safe and an effective alternative option for patients with moderate to severe cholangitis, even with significant pre-morbid conditions, with acceptable adverse events rate.Type of adverse events/number of patients bleeding - 1 patient; intrahepatic cholestasis - 1 patient; hemobilia - 2 patients; bile leak - 1 patient; death 2 days after procedure due to massive pulmonary embolism - 1 patient; death 3 months after procedure - 10 patient.This literature article requires 2 reports.The related patient identifiers are as follows: (b)(6): for adverse events; (b)(6): for patient death.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

Since the literature described "gif uct180", olympus selected "gf-uct180" 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.

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 new information received from the author.B5 has been updated accordingly.Also, a correction has been made to h8 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 additional information was received from the author: no olympus device malfunctions occurred during any of the procedures described in the article.In addition, an olympus device did not cause or contribute to any of the patient adverse events described in the article.

• Brand Name: EVIS EXERA II 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: 16658793
• MDR Text Key: 312461426
• Report Number: 3002808148-2023-03213
• Device Sequence Number: 1
• Product Code: ODG
• UDI-Device Identifier: 04953170356339
• UDI-Public: 04953170356339
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K093395
• 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: 07/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/31/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: GF-UCT180
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/30/2023
• 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): Death