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

Model Number GIF-XP290N

Device Problem Mechanical Jam (2983)

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

Event Date 01/04/2023

Event Type  malfunction  

Event Description

The customer reported that during a diagnostic upper gastrointestinal endoscopic procedure, the evis lucera elite gastrointestinal videoscope was unable to be removed because it was caught in the curved rubber portion of the endoscope after several attempts, the endoscope was successfully removed.There was no procedure delay and the procedure was completed.The patient was discharged the same day and there was no report of patient harm or injury due to the event.

Manufacturer Narrative

The suspect device has been returned to olympus, however, an evaluation has not been completed at this time.The investigation is ongoing; therefore, the root cause of the reported event cannot be determined at this time.However, if additional information becomes available this report will be supplemented accordingly.

Event Description

The customer confirmed: when trying to remove the scope, the angle did not return / originally there was esophageal stricture and it was difficult to insert, etc.The transnasal scope was inserted through the nose, and when he tried to remove the scope, it got stuck around the curved rubber and could not be removed.It seems that he hesitated whether to cut the scope because he could not pull it out forcibly, but he managed to remove it by rotating the insertion part.The customer pulled the device out by turning it to the right, but perhaps because of that, a pinhole was generated in the curved rubber.The procedure was a health checkup.The patient did not receive additional anesthesia.It seems that there was a slight delay due to the fact that the insertion tube could not be removed.The patient was a female and there was no bleeding when it was inserted through the nose.There was no noticeable reaction such as pain while it could not be removed, and even after that.Nothing was said.It seems that the scope was difficult to insert because the nostril was narrow or there was a protruding part inside.The procedure was completed and no need to switch to another endoscope.It is unknown if the device was inspected before use.The part of the body that was caught is unknown.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation with device evaluation and correction to the initial with information inadvertently left out.The device was returned to olympus for inspection, and the customer's complaint/reportable malfunction was not confirmed.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, it is possible the phenomenon occurred while turning the endoscope around clockwise.It was noted that the bending section cover had a pinhole, was torn and significant scratches were found around the glue section and the insertion section.When and how the tear and scratches occurred were not specified from the actual item.The relationship with the suggested event is unknown.The root cause could not be identified.The event can be prevented by following the instructions for use which state: "operation manual, important information ¿ please read before use, ¦ precautions for transnasal insertion for gif-xp290n.·a patient¿s sneezing may bend the endoscope forcefully, and it may damage the endoscope.This could cause patient bleeding and perforation, and the endoscope could become lodged and difficult to withdraw.If any irregularity is observed, stop using the endoscope and withdraw it from the patient safely." in addition, the following non-reportable malfunctions were found during the device evaluation: scope connector air leak, angle play, insufficient angle, scope connector liquid leakage, bending section cove adhesive part chipped, image guide snake tube scratches, scope connector damage, and suction cylinder nut paint peeling.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: 16375802
• MDR Text Key: 309593367
• Report Number: 9610595-2023-02501
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 05/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/14/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: GIF-XP290N
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/30/2023
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/09/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/17/2018
• 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 Sex: Female