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

Model Number TJF-Q290V

Device Problem Device Contamination with Body Fluid (2317)

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

Event Date 10/13/2023

Event Type  malfunction  

Event Description

The customer reported to olympus the evis lucera elite duodenovideoscope had mucosal tissue on the end of the device.The issue was found during reprocessing after completing a therapeutic endoscopic retrograde cholangiopancreatography procedure.This event was reported on two separate occasions.There were no reports of patient harm.This report is related to linked patient identifier (b)(6).

Manufacturer Narrative

The device was not returned to olympus for evaluation.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.The device history record was unable to be reviewed for this device since the serial/lot number was not provided.However, olympus only releases products to market that meet all manufacturing specifications and final product release criteria.Based on the results of the investigation, the root cause could not be determined.However, the reported issue was likely caused by the following: 1.If the user conducts suction operation when the opening section of the distal end of the endoscope is close to a mucosal surface, mucosal tissue is suctioned into the distal cover.If the user withdraws the endoscope under this condition, mucosal tissue gets damaged with the edge of the distal cover.2.The distal cover cracks along the center line due to inappropriate attachment to the endoscope.If the distal end of the endoscope is pressed to the mucosal surface under this condition, mucosal tissue gets caught at the cracked site and gets damaged, even though suction operation is not conducted.The event can be detected/prevented by following the instructions for use (ifu) which state: operation manual : chapter 4 ¿operation¿ section 4.4 ¿withdrawal of the endoscope¿.Chapter 3 ¿preparation and inspection¿ section 3.5 ¿attaching accessories to the endoscope¿.¿warning: take caution applying suction when the distal end is in contact with the mucosal surface.The suction can cause the distal end to aspirate the mucosal membrane.Moving or withdrawing the endoscope under this condition may cause patient injury and/or bleeding.This can be more common while degassing in the stomach, suctioning debris, and operating in a narrow lumen (e.G., esophagus, duodenum).To prevent patient injury and bleeding, make sure to: - only apply suction when the endoscope is stationary.- after releasing the suction valve, check the endoscopic image to confirm that the mucosal membrane is not aspirated before moving the endoscope.Releasing the suction valve might not immediately release.The mucosal membrane if it becomes aspirated.¿ ¿warning: never use a single use distal cover with cracks or pinholes.Replace it with a new one.If a single use distal cover with cracks or pinholes is used, it could fall off during the examination and/or, it may cause thermal injury due to electric current leaks from cracks or pinholes when high-frequency cauterization treatment is performed.Also, using the single use distal cover with cracks may cause patient injury due to sharp edges.¿ this supplemental report includes additional details received regarding the event.The information has been added to b5.Also, a correction has been made to g2 to provide information that was inadvertently not included in the initial medwatch.Olympus will continue to monitor field performance for this device.

Event Description

The customer provided the following clarification regarding the reported event: mucosal tissue was observed on the tip of the device while in the sink.Three days later, mucosal tissue was found in the same sink.It was confirmed that it was the same mucosal tissue from the previous event (as noted three days prior) and not related to another event.

• Brand Name: EVIS LUCERA ELITE DUODENOVIDEOSCOPE
• Type of Device: DUODENOVIDEOSCOPE
• 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: 18109235
• MDR Text Key: 329320562
• Report Number: 9610595-2023-16899
• Device Sequence Number: 1
• Product Code: FDT
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 12/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: TJF-Q290V
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/14/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: MAJ-2315 SINGLE USE DISTAL COVER