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 Problems Cardiac Arrest (1762); Respiratory Arrest (4461)

Event Date 11/22/2023

Event Type  Injury  

Manufacturer Narrative

The suspect device referenced in this report has not been returned to olympus.Additional information is being requested.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or if additional information is received.

Event Description

An olympus representative reported on behalf of the customer that when the therapeutic endoscopic retrograde cholangiopancreatography (ercp) procedure was completed and the evis lucera elite duodenovideoscope was removed, the patient's breathing became irregular, and his heart and lungs stopped temporarily.It was also reported that the single use distal cover fell off inside the mouth while the scope was removed.The patient was revived and is currently in good condition.The user facility determined that the cardiopulmonary arrest was due to the patient having been given too much anesthesia.The device was inspected prior to use without any issues noted.This event requires 2 reports.The related patient identifiers are as follows: 1.(b)(6) - single use distal cover.2.(b)(6) - evis lucera elite duodenovideoscope this medwatch report is for (b)(6).

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 3 years since the subject device was manufactured.Based on the results of the investigation, the reported event (distal cover detachment) was likely due to insufficient attachment to the scope.Therefore, the distal cover likely detached from the scope due to stress during use.However, the root cause of the reported adverse event and device defect could not be determined.The event can be detected/prevented by following the instructions for use (ifu)in sections: operation manual: chapter 3 ¿ (section 3.5) prevention measures.Operation manual: chapter 4 ¿ (section 4.1) inspection method.Olympus will continue to monitor field performance for this device.

Manufacturer Narrative

This report is being supplemented to provide additional information as reflected in b5.

Event Description

Olympus received further information indicating that the cardiac arrest occurred after the distal cover fell in the patient's mouth.The distal cover fell at a hand-collectible position at the front of the throat and was retrieved by hand, so it was thought that the distal cover did not contribute to the patient's cardiac arrest.The procedure was not prolonged and was carried out as usual.The patient did not require any other additional intervention or admission to the intensive care unit (icu).

• 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: 18328319
• MDR Text Key: 330510881
• Report Number: 9610595-2023-19586
• 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,User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 03/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2023
• 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: 03/14/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/12/2021
• 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/UNKNOWN LOT NO.
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 60 YR
• Patient Sex: Male
• Patient Race: Asian