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 03/15/2021

Event Type  Injury  

Manufacturer Narrative

The suspect device has not been returned to olympus for evaluation.The investigation is in process.Once the investigation has been completed, a supplemental report will be submitted with device evaluation results.This report has been submitted by the importer under this mdr report number 2429304 - 2022 - 00074.

Event Description

Fda mdr report number 1000513161-2022-00003.Olympus was notified by fujifilm healthcare americas, during a literature search performed (b)(6) 2022, they identified the study used a fujifilm eg-580ut or an olympus gf-uct180 on patients.According to fujifilm, the referenced scientific literature described five (5) procedure-related adverse events, of which four (4) resulted in death.Fujifilm stated the specific details of the procedure and the device used are not available and the event date is unknown.Fujifilm also reported the relationship between eg-580ut and the adverse events/deaths cannot be found in the report correlated literature nor is it confirmed.No patient identifiers noted in article.Multiple attempts to fujifilm to identify the referenced literature article were unsuccessful.No additional information available.This event includes 2 complaints: (b)(6): deaths.(b)(6): adverse events.This report is 2 of 2 for (b)(6): adverse events.

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 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.Olympus will continue to monitor field performance for this device.

• 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 Contact: masaharu hirose ; 3-1 okamiyama; odakura, nishigo-mura,; nishishirakawa-gun, fukushima 961-8-061 ; JA 961-8061 ; 426422891
• MDR Report Key: 15587030
• MDR Text Key: 301566112
• Report Number: 3002808148-2022-03047
• Device Sequence Number: 1
• Product Code: ODG
• UDI-Device Identifier: 04953170356339
• UDI-Public: 04953170356339
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K093395
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Literature
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2022
• 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?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/11/2022
• 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