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

Model Number GIF-H290Z

Device Problems Partial Blockage (1065); Failure to Clean Adequately (4048)

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

Event Type  malfunction  

Event Description

A customer reported a drainage failure in the evis lucera elite gastrointestinal videoscope.There were no reports of patient harm.Upon evaluation, foreign material was discovered in the device¿s nozzle.This medical device report (mdr) is being submitted to capture the reportable malfunction found during evaluation.

Manufacturer Narrative

A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 7 years since the device was manufactured.The device was cleaned, disinfected, and sterilized the product before it was sent in for repair.According to the customer, it was unknown when the foreign material adhered to the nozzle, there was no delay in the start of the pre-cleaning, the air/water nozzle was flushed with air and water, the nozzle was cleaned with lint-free cloths/brushes/sponges and the air/water nozzle was flushed with detergent solution.The device was returned to an olympus repair facility, and an evaluation of the device was performed.Upon inspection and testing of the unit, foreign material was discovered in the device nozzle, caused by insufficient cleaning.In addition, stretched angle wires, chipped adhesive on the a-rubber, a dirty light guide lens, a scratched and discolored connecting tube, a damaged charged coupled device (ccd), and a stained objective lens were discovered.Based on the obtained information, the root cause of remaining of the foreign material was unable to be specified.This issue is addressed in the instructions for use (ifu): chapter 3: preparation and inspection, section 3.3 inspection of the endoscope and section 3.8 inspection of the endoscopic system¿ as below.[inspection of the endoscope] 8.Inspect the air/water nozzle at the distal end of the endoscope¿s insertion section for abnormal swelling, bulges, dents, or other irregularities.[inspection of the objective lens cleaning function] inspection of the water feeding function 1.Cover the spray valve hole with your finger.2.Depress the valve all the way (till the 2nd step) and confirm that water flow is observed in the entire endoscopic image.Inspection of the spray function 1.Cover the spray valve hole with your finger.2.While keeping the spray valve hole covered, depress the valve till the first stop position (till the 1st step).Confirm that emission of water spray is observed in the entire 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 965-8 520; JA 965-8520
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 17052426
• MDR Text Key: 317058475
• Report Number: 9610595-2023-08335
• Device Sequence Number: 1
• Product Code: FDS
• UDI-Device Identifier: 04953170334146
• UDI-Public: 04953170334146
• 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
• Report Date: 06/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/02/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: GIF-H290Z
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/07/2023
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/07/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/10/2015
• 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