MAUDE Adverse Event Report: SHIRAKAWA OLYMPUS CO., LTD. EUS EXERA ULTRASONIC GASTROVIDEOSCOPE

Model Number GF-UCT160-OL5

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

Patient Problems Abdominal Pain (1685); Hemorrhage/Bleeding (1888); Pancreatitis (4481)

Event Date 12/28/2021

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.Once the investigation has been completed, a supplemental report will be submitted with device evaluation results.

Event Description

Olympus reviewed the following literature titled "management of non-functional pancreatic neuroendocrine tumors by endoscopic ultrasound-guided radiofrequency ablation: retrospective study in two tertiary centers." patients and methods: a bicentric retrospective study was performed that included patients with histologically confirmed nf pnets who were consecutively treated by eus-rfa.Results: in 27 patients, eusrfa was successfully performed.All patients had sporadic g1 lesions.Overall, 9/ 27 lesions were cystic.The mean hospital stay was 3.2 days.Complete treatment response was confirmed in 25/27patients on cross-sectional imaging.Two patients had two eus-rfa sessions until complete necrosis was observed.Periprocedural acute pancreatitis occurred in 4/27 , three of them were treated by endoscopic cystogastrostomy.One patient underwent secondary surgery.The histopathology of the resected specimen revealed 3 mm of residual tumor tissue.Type of adverse events/number of patients.Mild postprocedural abdominal pain -3.Acute pancreatitis -1.Periprocedural bleeding -2 (slight or minor).Acute pancreatitis -3 (table 3).This literature article requires 4 reports.The related patient identifiers are as follows: (b)(6) as patient 1 for acute pancreatitis.(b)(6) as patient 2 for acute pancreatitis.(b)(6) as patient 3 for acute pancreatitis.(b)(6) for postprocedural abdominal pain, acute pancreatitis, and periprocedural bleeding.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.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 corrections to e4 and g2 to provide information that was inadvertently not included on the initial medwatch.Olympus will continue to monitor field performance for this device.

• Brand Name: EUS EXERA ULTRASONIC GASTROVIDEOSCOPE
• Type of Device: ULTRASONIC GASTROVIDEOSCOPE
• Manufacturer (Section D): SHIRAKAWA OLYMPUS CO., LTD.; 3-1 okamiyama; odakura, nishigo-mura,; nishishirakawa-gun, fukushima 961-8 061; JA 961-8061
• Manufacturer Contact: masaharu hirose ; 3-1 okamiyama; odakura, nishigo-mura,; nishishirakawa-gun, fukushima 961-8-061 ; JA 961-8061 ; 426422891
• MDR Report Key: 15674618
• MDR Text Key: 302431348
• Report Number: 3002808148-2022-03555
• Device Sequence Number: 1
• Product Code: ODG
• Combination Product (y/n): N
• Reporter Country Code: SZ
• 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: 01/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: GF-UCT160-OL5
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/16/2023
• 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: UNKNOWN, EUSRA RF ELECTRODE
• Patient Outcome(s): Other; Required Intervention
• Patient Sex: Prefer Not To Disclose