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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. VISERA ELITE XENON LIGHT SOURCE

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OLYMPUS MEDICAL SYSTEMS CORP. VISERA ELITE XENON LIGHT SOURCE Back to Search Results
Model Number CLV-S190
Device Problem No Display/Image (1183)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/11/2018
Event Type  malfunction  
Manufacturer Narrative
The subject clv-s190 was not returned to olympus medical systems corp. (omsc) yet. Omsc will investigate the subject clv-s190 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. The clv-s190 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 user used the subject xenon light source clv-s190 and video system center otv-s190 in the laparoscopic surgery of gynecology. At the beginning of the procedure, the user inserted the endoscope into the patient¿s body. At that time, the color of the endoscopic image became abnormal and the endoscopic image became dark. The user replaced the subject clv-s190 and otv-s190 with the similar device and completed the procedure. There was no report of the patient's injury regarding this event.
 
Manufacturer Narrative
The subject clv-s190 was returned to olympus medical systems corp. (omsc) for evaluation. Omsc continued to investigation the referenced devices, however the phenomenon could not reproduced. Omsc determined that the subject clv-s190 met specifications. The exact cause of the reported event could not be conclusively determined, however there is possibility of this phenomenon is attributed to the following. The user handling of the device was inappropriate, such as the temporal ingress of liquid and/or foreign material into the subject clv-s190. It caused by the usage environment of the facility, such as the temporal malfunction due to the noise. Olympus stated the appropriate handling of clv-s190 and the counter measures against abnormalities in the instruction manual of clv-s190. 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 NameVISERA ELITE XENON LIGHT SOURCE
Type of DeviceXENON LIGHT SOURCE
Manufacturer (Section D)
OLYMPUS MEDICAL SYSTEMS CORP.
2951 ishikawa-cho
hachioji-shi, tokyo-to
MDR Report Key8017559
MDR Text Key125637568
Report Number8010047-2018-02080
Device Sequence Number1
Product Code GCT
Combination Product (y/n)N
PMA/PMN Number
K061313
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
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 Received10/29/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberCLV-S190
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/19/2018
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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