MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. HINODE PLANT SINGLE USE DISTAL COVER

Model Number MAJ-2315

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  

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

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

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: SINGLE USE DISTAL COVER
• Type of Device: DISTAL COVER
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP. HINODE PLANT; 34-3 hirai, hinode-machi; nishitama-gun, tokyo 190-0 182; JA 190-0182
• Manufacturer (Section G): OLYMPUS MEDICAL SYSTEMS CORP. HINODE PLANT; 34-3 hirai, hinode-machi; nishitama-gun, tokyo
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 18328250
• MDR Text Key: 330510433
• Report Number: 3003637092-2023-00249
• Device Sequence Number: 1
• Product Code: FDT
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K220587
• 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
• Report Date: 01/02/2024

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: MAJ-2315
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/22/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: TJF-Q290V/SERIAL NO. (B)(6).
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 60 YR
• Patient Sex: Male
• Patient Race: Asian