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

Model Number GIF-H290Z

Device Problem No Display/Image (1183)

Patient Problem Insufficient Information (4580)

Event Date 03/01/2023

Event Type  Injury  

Manufacturer Narrative

The suspect device will reportedly not be returned to olympus.Additional information is being requested.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.

Event Description

An olympus representative reported to olympus on behalf of the customer that the image on the evis lucera elite gastrointestinal videoscope suddenly disappeared in the middle of a diagnostic gastrointestinal endoscopy.The screen was reportedly cut off about 70% after the examination started and the screen went black.The device was powered off and on repeatedly, but the issue persisted.The customer was advised by olympus customer service center that it was possible that the telecommunication between the endoscope body and scope did not work well, and the image was interrupted.The customer was further advised to clean the electrical contact part of the scope with disinfectant alcohol.The customer reported that they will give it a try.When the scope was reconnected after stopping the procedure, the problem was resolved.Additional information has been requested regarding this event.

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.It has been over 6 years since the subject device was manufactured.Based on the results of the investigation, the event was likely caused by a stain on the electrical contacts with the system.However, the root cause could not be identified.Olympus will continue to monitor field performance for this device.

Event Description

Although additional information was requested regarding the event, no further details were provided.

• 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: 16653144
• MDR Text Key: 312400859
• Report Number: 9610595-2023-05357
• 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,Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 05/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: GIF-H290Z
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/02/2023
• Initial Date FDA Received: 03/31/2023
• Supplement Dates Manufacturer Received: 04/13/2023
• Supplement Dates FDA Received: 05/03/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/27/2017
• 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: CV-290/7725627, CLV-290/7726596
• Patient Outcome(s): Other