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U.S. Department of Health and Human Services

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

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OLYMPUS MEDICAL SYSTEMS CORP. EVIS LUCERA XENON LIGHT SOURCE Back to Search Results
Model Number CLV-260
Device Problem No Display/Image (1183)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/19/2018
Event Type  malfunction  
Manufacturer Narrative
The subject clv-260 has not been returned to olympus medical systems corp. (omsc) yet. Omsc will investigate the subject clv-260 to identify the root cause of this failure phenomenon when omsc receives it. The exact cause of the reported event could not be conclusively determined at this time. There were no further details provided. If significant additional information is received, this report will be supplemented.
 
Event Description
Near the end of ercp, the facility tried to place the pancreatic stent in the patient's body. At that time, the endoscopic image displayed on an unspecified monitor was disappeared. The facility continued and completed the procedure without using the endoscopic image. But, the facility could not confirm whether the pancreatic stent was definitely placed in the patient's body. There was no report of the patient's injury regarding this event. At this time, the facility has no plan to perform the reoperation for the patient.
 
Manufacturer Narrative
This supplemental report is submitting to correct "device product code".
 
Manufacturer Narrative
The subject clv-260 was not returned to olympus medical systems corp. (omsc) for evaluation. However, the subject clv-260 was returned to repair center of olympus for repair. As a result of investigation by repair center, it was found that the fuse was blown. Therefore omsc concluded that this event attributed to fuse blown. Omsc surmised that there was the possibility the fuse was degraded with age and/or overcurrent was accidental applied to the subject clv-260. The clv-260 instruction manual states the corresponding method when there is an abnormality for the device. Olympus checked the device history record of the subject clv-260, there was no irregularity found. There were no further details provided. If significant additional information is received, this report will be supplemented.
 
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Brand NameEVIS LUCERA XENON LIGHT SOURCE
Type of DeviceXENON LIGHT SOURCE
Manufacturer (Section D)
OLYMPUS MEDICAL SYSTEMS CORP.
2951 ishikawa-cho
hachioji-shi, tokyo-to
MDR Report Key7680575
MDR Text Key114453082
Report Number8010047-2018-01320
Device Sequence Number1
Product Code GCT
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Type of Report Initial,Followup,Followup
Report Date 03/15/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/12/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberCLV-260
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received02/20/2019
Is This a Reprocessed and Reused Single-Use Device? No

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