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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 Overheating of Device (1437)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
The subject clv-190 has not been returned to olympus medical systems corp. (omsc) yet. Omsc will investigate the subject clv-190 to identify the root cause of this failure phenomenon when omsc receives it. The clv-190 instruction manual states the corresponding method when there is an abnormality for the device. There were no further details provided. If significant additional information is received, this report will be supplemented.
 
Event Description
The local field service hotline received a report regarding overheating of the subject clv-190 that might burn the patient. There was no report of the patient¿s and/or the user¿s injury regarding this event. There was no further information provided.
 
Manufacturer Narrative
The subject clv-190 was not returned to olympus medical systems corp. (omsc), omsc could not investigate it. Omsc checked the device history record of the subject clv-190, and there was no irregularity found. Regarding this event, omsc has received following information so far. Overheating of the subject clv-190 might cause that burn the patient. An olympus local engineer evaluated the subject clv-190, there was no abnormality found. The root cause of this event could not be conclusively determined, because omsc could not investigate the subject clv-190. However, based on information omsc received so far, omsc surmised that the reported overheating of the subject clv-190 was possibly caused by the following. Since the subject clv-190 was placed in an environment where the ventilation grills of the subject clv-190 was covered, the heat generated from the lamp could not be exhausted to outside and the subject clv-190 overheated. Since the cooling fan inside the subject clv-190 did not work due to deterioration, the heat generated from the lamp could not be exhausted to outside and the subject clv-190 overheated. There were no further details provided. If significant additional information is received, this report will be supplemented.
 
Manufacturer Narrative
This supplemental report is submitting to correct "device product code".
 
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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
MDR Report Key7640435
MDR Text Key112892124
Report Number8010047-2018-01224
Device Sequence Number1
Product Code GCT
Combination Product (y/n)N
PMA/PMN Number
K112680
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
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 Received06/27/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberCLV-190
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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