MAUDE Adverse Event Report: AIZU OLYMPUS CO., LTD. EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE

Model Number GIF-H185

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

Patient Problems Sepsis (2067); Gastrointestinal Hemorrhage (4476)

Event Date 10/03/2022

Event Type  Injury  

Manufacturer Narrative

The suspect device has not been returned to olympus for evaluation.The investigation is in process.The literature article doi: 10.3389/fcimb.2022.939137 provided 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 "endoscopic treatment of pancreaticopleural fistulas." this prospective study was evaluated the effectiveness of various endoscopic techniques for the treatment of patients with pancreaticopleural fistulas (ppfs) in 22 patients.The eendoscopic retrograde cholangiopancreatography was performed in 21/22 (95.45%) patients, confirming the diagnosis of ppf.The clinical success was achieved in 21/22 (95.45%) patients.The mean total time of endotherapy was 191 (range 88¿712) days.Long-term success of endoscopic treatment of ppfs during one year follow-up period was achieved in 19/22 (86.36%) patients.This study results concludes that endoscopic treatment is effective for managing post-inflammatory ppfs.The preferred treatment method is passive transpapillary drainage (prosthesis of the main pancreatic duct).Type of adverse events/number of patients.Upper gastrointestinal bleeding - 3 patients.Sepsis - 1 patient.This literature article requires 2 reports.The related patient identifiers are as follows: (b)(6) :tjf-q180v.(b)(6) :gif-h185.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 through follow-up.Additional correction to the initial e3.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: in the medical opinion of the author, the olympus device did not cause malfunction nor the adverse events reported.

• Brand Name: EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE
• Type of Device: GASTROINTESTINAL 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
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 16117253
• MDR Text Key: 306879513
• Report Number: 9610595-2023-00331
• Device Sequence Number: 1
• Product Code: FDS
• Combination Product (y/n): N
• Reporter Country Code: PL
• 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: 06/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/06/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: GIF-H185
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/25/2023
• 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): Required Intervention