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

Model Number GIF-H290T

Device Problems Partial Blockage (1065); Particulates (1451)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

The device was returned to an olympus repair facility, and an evaluation of the device was performed.During the evaluation, foreign material was discovered clogging the device nozzle.The customer's originally reported issue of collapsed insertion tube was also confirmed.Additionally, the following findings were noted: improper insertion of treatment tool.Lg lens adhesive part cloudy.A-rubber adhesive part crack.Objective lens adhesive part cloudy.Tip cover discoloration.A-rubber adhesive part missing.A-rubber adhesive part cloud.Flexible tube scratches.Flexible tube wrinkles.Switch 1 scratches.The investigation is ongoing and follow up with the user facility is currently being performed.A supplemental report will be submitted upon completion of the investigation or if any additional information is provided by the user facility.

Event Description

An olympus representative reported on behalf of the customer that their evis lucera elite gastrointestinal videoscope had a collapsed insertion tube.Upon inspection and testing of the returned unit, foreign material was found to be clogging the device nozzle.There were no reports of patient or user harm associated with this event.This medical device report (mdr) is being submitted to capture the reportable malfunction found during evaluation.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Based on the results of the investigation, the root cause of the event was unable to be identified.The foreign material was unable to be identified.It was confirmed that there was no deformation of the air/water nozzle.It was unclear whether the reprocessing was performed according to the instructions for use (ifu).The inspection method for the event is described as follows in the ifu "chapter 3 preparation and inspection 3.3 inspection of the endoscope and 3.8 inspection of the function in combination with related equipment".[inspection of entire endoscope] 9.Visually check that there are no abnormal protrusions, dents, or deformations in the air/water nozzle at the tip of the endoscope.[inspection of objective lens surface cleaning function] ¿when using the air/water button 1.Cover the air/water button hole with your finger.2.Push the button while covering the hole.Ensure that water flows across the endoscopic image." 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 (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: 16386823
• MDR Text Key: 309975757
• Report Number: 9610595-2023-02661
• Device Sequence Number: 1
• Product Code: FDS
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 04/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: GIF-H290T
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/17/2023
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/17/2023
• Initial Date FDA Received: 02/16/2023
• Supplement Dates Manufacturer Received: 04/04/2023
• Supplement Dates FDA Received: 04/27/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/09/2021
• 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