MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. EVIS EXERA III XENON LIGHT SOURCE

Model Number CLV-190

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Air Embolism (1697)

Event Date 10/30/2018

Event Type  Injury  

Manufacturer Narrative

The user facility has stated that the device will remain at their site and will not return to olympus for evaluation. The cause of the complaint cannot be confirmed. A review of the device service history shows no olympus service since 2016. Despite followup attempts by phone and in writing, no further information is available regarding the device malfunction, mechanism of air embolism injury by the device, or type of injury. It has not been confirmed that the event involved any report of over-inflation by the device. There is also no further information on the current status of the patient. As a preventive measure against device malfunction, the instructions manual states that the device should be functionally inspected prior to the procedure, along with the other devices used. The inspection includes a verification of airflow function and verification of airflow indicators on the device. The instructions manual also warns that during the procedure, ¿anytime you observe an irregularity in a light source function, stop the examination immediately. ¿ the instructions manual notes, air and water is not fed even if the airflow indicator ¿on¿ is lighting when no endoscope is connected to the light source. ¿ and that the air/water function ¿is available only when a compatible fiber endoscope or videoscope is connected. ¿ the instructions manual also states, ¿in case of light source failure or malfunction, always keep another light source in the room ready for use. ¿.

Event Description

1 of 2. Olympus was informed that during an ercp procedure, the patient had an air embolism injury and was currently in the intensive care unit with possible compromised anatomy.

• Brand Name: EVIS EXERA III XENON LIGHT SOURCE
• Type of Device: XENON LIGHT SOURCE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to
• Manufacturer Contact: connie tubera ; 2400 ringwood avenue; san jose, CA 95131 ; 4089355124
• MDR Report Key: 8084443
• MDR Text Key: 127591743
• Report Number: 2951238-2018-00707
• Device Sequence Number: 1
• Product Code: GCT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131780
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 03/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/19/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Model Number: CLV-190
• Device Catalogue Number: CLV-190
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Event Location: No Information
• Date Manufacturer Received: 02/20/2019
• 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 Treatment Data

Date Received: 11/19/2018 Patient Sequence Number: 1

Treatment

OLYMPUS TJF-Q180V SCOPE; UNKNOWN MODEL RE-USABLE VALVES