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

Model Number TJF-Q290V

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 05/01/2023

Event Type  Injury  

Event Description

The customer reported to olympus the evis lucera elite duodenovideoscope cover came off during a diagnostic endoscopic retrograde cholangiopancreatography.After the scope was removed from the patient, the physician noticed that the cover was missing.The doctor retrieved the cover from the duodenal bulb with another scope and grasping forceps and no additional procedures were necessary.It was stated that no mucosal damage occurred.There were no reports of patient harm.Patient identifier (b)(6) is for the evis lucera elite duodenovideoscope.Patient identifier (b)(6) is for the single use distal cover.

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.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been less than 1 year since the subject device was manufactured.Based on the results of the investigation, the root cause of the reported event could not be determined.However, the distal cover likely fell off the scope due to the following: 1.Antifogging agent adhered to the cover, which led to breakage due to chemical attack.As a result, the cover came to be easily detached from the endoscope.2.The cover was insufficiently attached to the endoscope, which caused the cover to easily be detached from the endoscope.3.The cover was pushed at an angle when attached to the endoscope, which led to breakage of the cover.As a result, the cover came to be easily detached from the endoscope.The event can be detected/prevented by following the instructions for use (ifu) which state: ¿chapter 3 preparation and inspection, section 3.5 attaching accessories to the endoscope as below: [attaching the single use distal cover] 1 confirm that the instrument channel outlet of the distal end is opened.2 if the instrument channel outlet is not opened, move the elevator control lever in the opposite direction of the ¿u¿ direction until the forceps elevator stops to make the instrument channel outlet opened.3 gently hold the distal part of the bending section and the single use distal cover.Align the opening side of the single use distal cover with the lenses side of the distal end.4 put your finger onto the center on the top of the single use distal cover and push the top of the single use distal cover straight onto the distal end of the endoscope until the hook of the distal ring is completely visible within the opening of the single use distal cover.5 hold the distal part of the bending section.Pull the single use distal cover gently to confirm that the single use distal cover on the distal end of the endoscope does not slip and come off.6 twist the single use distal cover gently in both directions and confirm that the single use distal cover on the distal end of the endoscope does not slip and come off.7 confirm that the single use distal cover is free of cracks or deformation.8 confirm that there is no adhesion of foreign materials between the distal end of the endoscope and the single use distal cover.¿ olympus will continue to monitor field performance for this device.

Event Description

Additional information was reported, and indicated that there was a 5 minute procedural delay due to the device issues previously reported.It was unknown if there were any adverse health effects due to the delay.Additional information regarding the outcome was requested but was unknown by the reporter and unable to be provided.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information obtained from the customer regarding the reported 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: 17019148
• MDR Text Key: 316122052
• Report Number: 9610595-2023-08153
• 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: Other,Foreign,Health Professional,User Facility,Company Representative,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 06/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/30/2023
• Is this an Adverse Event Report?: Yes
• 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: 06/26/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/27/2022
• 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: EVIS LUCERA ELITE DUODENOVIDEOSCOPE - LOT H2921.
• Patient Outcome(s): Required Intervention