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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 Device Operational Issue (2914)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/31/2017
Event Type  malfunction  
Manufacturer Narrative
The customer returned the clv-190 light source to olympus for evaluation. The user complaint was not confirmed. A visual inspection was performed on the returned device and no physical anomalies or irregularities were observed. The pump air pressure and activation were tested using a laboratory air pressure gauge. The air pump was toggled between on and standby, and functioned as intended. An air pump pressure check was performed and the device passed all olympus specifications. Based on the evaluation, the device passed the air pressure pump test. The low, medium and high modes measured within olympus specifications. Pump is working and fully functional. The exact cause of the reported event could not be determined. The clv-190 instruction manual warns users in section 5. 9 ¿air/water feeding. ¿ ¿over-insufflating the lumen may cause patient pain, injury, bleeding, gas embolism, and/or perforation. ¿.
 
Event Description
Olympus was informed that during three different post op evaluations, three patients experienced abdominal pain and gas due to over-inflation from the device. The user facility reported that the device had a continuous air flow, while the air function was set to standby. The patients did not require any additional treatment or hospitalization. The patients were discharged home in stable condition. In addition, it was reported that during the procedure the user facility¿s technician was able to confirm a continuous air flow after the ucr (insufflator) was powered off and the water bottle was disconnected from the side of the scope. This is 3 of 3 reports.
 
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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 Key7627945
MDR Text Key112470186
Report Number2951238-2018-00360
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 user facility
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/08/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/21/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberCLV-190
Device Catalogue NumberCLV-190
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/06/2018
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received02/20/2019
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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