MAUDE Adverse Event Report: AIZU OLYMPUS CO., LTD. EVIS LUCERA ELITE GASTROINTESTINAL VIDEOSCOPE

Model Number GIF-H290

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

Patient Problems Fistula (1862); Hemorrhage/Bleeding (1888); Unspecified Infection (1930); Multiple Organ Failure (3261)

Event Date 04/17/2022

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

Event Description

Olympus reviewed the following literature titled "a novel strategy for transmural stent removal in necrotizing pancreatitis undergoing endoscopic transmural necrosectomy".Literature summary: this retrospective, nested, case-control study aimed to compare the strategies for transmural stent removal in necrotizing pancreatitis undergoing endoscopic transmural necrosectomy (etn).Among 74 patients, case group (n=37) and control group (n=37).Three patients in case group and 1 patient in control group needed additional etn after stent removal.Nearly all patients achieved clinical success.There was no difference in disease-related or stent-related complications.Case group had a trend of shorter length of stent placement.The study concluded that the novel strategy of transmural stent removal during last necrosectomy might be feasible which needed further validation.Compared with the convention strategy, the novel strategy avoids one endoscopy procedure and should be considered in clinical practice.Type of adverse events/number of patients.Transfer to open surgery 3.New-onset organ failure - 3 patients.New-onset infection - 6 patients.Abdominal bleeding - 4 patient.Gastrointestinal bleeding - 6 patients.Gastrointestinal fistula - 5 patients.Transient fever - 11 patients.Death - 15.The deaths were determined to not be reportable.This report is for (b)(6) for the 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 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.Olympus will continue to monitor field performance for this device.

• Brand Name: EVIS LUCERA ELITE 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 Contact: masaharu hirose ; 3-1-1 niiderakita; aizuwakamatsu-shi, fukushima 965-8-520 ; JA 965-8520 ; 426422891
• MDR Report Key: 15269586
• MDR Text Key: 298388721
• Report Number: 9610595-2022-01180
• Device Sequence Number: 1
• Product Code: FDS
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 09/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/22/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: GIF-H290
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/01/2022
• 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
• Treatment: NON-OLYMPUS NEEDLE
• Patient Outcome(s): Other