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

Model Number GIF-H190N

Device Problems Image Display Error/Artifact (1304); Optical Problem (3001)

Patient Problem Cancer (3262)

Event Date 12/01/2022

Event Type  Injury  

Manufacturer Narrative

The device referenced in this report was not returned to olympus for evaluation.The root cause cannot be determined at this time.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.

Event Description

A user facility reported that during the use of the evis exera lll gastrointestinal videoscope for an upper gastrointestinal endoscopy, when the near point was in focus, the near point caused halation and the far point was dark.The physician stated this had been ongoing since the delivery of the device.Due to this defect, cancer was overlooked in a patient.A tumor was confirmed and treatment was performed at another facility, but an "oversight occurred separately from the confirmed tumor and was pointed out." it was stated that the tumor was found at the procedural hospital but was treated at another hospital.Early stage gastric cancer was found.It was also stated that cancer was identified separately from the tumor.Cancer treatment was completed and there was no impact on the patient's prognosis.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation and device evaluation.The device was returned to olympus for inspection, and the reported complaint could not be reproduced.Additional findings from the evaluation are as follows: peeling of plating (corrosion) at the electrical contact of the scope connector, angle down, peeling of adhesive around the light guide lens, scratch on the plastic distal end cover of the tip, chipped bending rubber adhesive, and a dent on the insertion part.No water leakage was detected because of a water leakage test for the equipment.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 5 years since the subject device was manufactured.Based on the results of the investigation, it is likely that insufficient angulation caused difficulty of operations such as retroflexed observation, which led to observation out of the range of correct depth of field.Also, it is likely that that peeling-off of coating of the electrical contact section of the scope connector could have caused unstable communication with the system side, which led to temporary occurrence of some kind of image failure.The following may have caused insufficient angulation: angulation operation while the endo therapy accessory was inserted, stress such as stroking the distal end section, application of excessive stress to the bending section while the angulation was operated or storing the endoscope while the up/down angulation lock and the right/left angulation lock lever were engaged to keep the bending figure.Furthermore, the peeling-off of coating of the electrical contact section of the scope connector likely caused unstable communication with the system side, which led to a temporary image failure.The cause of the peeling-off of the coating of the electrical contact section of the scope connector is likely due to corrosion from a chemical attack.Repeated contact with detergent solution and disinfectant solution caused accumulation of chemical stress.In addition, mechanical stress such as scraping during use was applied.Finally, peeling-off of glue around the light guide lens could have likely caused unnecessary light from the light guide lens not to be interrupted, which led to a flare which was reflected in the image.The peeling-off of glue around the light guide lens was likely caused by external force such as dropping or bumping since scratches were observed on the resin part of the distal end section.Olympus will continue to monitor field performance for this device.

• Brand Name: EVIS EXERA LLL 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: 16142259
• MDR Text Key: 307151770
• Report Number: 9610595-2023-00642
• Device Sequence Number: 1
• Product Code: FDS
• UDI-Device Identifier: 04953170305313
• UDI-Public: 04953170305313
• 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,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: GIF-H190N
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/22/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/10/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2018
• 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