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U.S. Department of Health and Human Services

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

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OLYMPUS MEDICAL SYSTEMS CORP. EVIS EXERA III XENON LIGHT SOURCE Back to Search Results
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.
 
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Brand NameEVIS EXERA III XENON LIGHT SOURCE
Type of DeviceXENON 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 Key8084443
MDR Text Key127591743
Report Number2951238-2018-00707
Device Sequence Number1
Product Code GCT
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K131780
Number of Events Reported1
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 Received11/19/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberCLV-190
Device Catalogue NumberCLV-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 Received02/20/2019
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
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