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U.S. Department of Health and Human Services

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

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OLYMPUS MEDICAL SYSTEMS CORP. EVIS LUCERA ELITE XENON LIGHT SOURCE Back to Search Results
Model Number CLV-290SL
Device Problem Display or Visual Feedback Problem (1184)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/19/2018
Event Type  malfunction  
Manufacturer Narrative
The subject clv-290sl has not been returned to olympus medical systems corp. (omsc) yet. Omsc will investigate the subject clv-290sl to determine the cause of this phenomenon when omsc receives it. Clv-290sl instruction manual states the corresponding method in case of an abnormality. There were no further details provided. If significant additional information is received, this report will be supplemented.
 
Event Description
During the emr procedure using the clv-290sl and cv-290, pcf-h290i, the user attempted to remove the suction tube from the pcf-h290i in order to attach a suction trap. At that time, as the scope connector part of the pcf-h290i was pushed, all areas in the image displayed on the monitor screen got dark to black and did not return to normal. The user moved with the patient to another operating room and completed the procedure using an unspecified similar system. After the procedure was completed, the same phenomenon was reproduced as the image lost on the monitor by applying the lateral stress to the scope connector of the pcf-h290i. There was no report of the patient¿s injury regarding this event other than moving the patient to another operating room or replacing of device.
 
Manufacturer Narrative
This is a supplemental report for mfr report #8010047 - 2018 ¿ 00649. The subject clv-290sl was returned to olympus medical systems corp. (omsc). Functional checks were performed with the subject clv-290sl (sn (b)(4)) which was connected to cv-290 (sn (b)(4)) and pcf-h290i(sn (b)(4) those were used when the reported malfunction occurred, and oev262h (omsc asset). As a result, the reported malfunction was not reproduced. Except for the reported phenomenon, "e216" scope communication error occurred. The investigation of the subject clv-290sl confirmed the following details: no abnormality was found in the subject clv-290sl when it was operated in the system stated above. The system including the subject cv-290 was turned on and off repeatedly. The pcf-h290i was applied lateral stress to the scope connector. Power was continuously supplied to the system including the subject clv-290sl. The system including the subject cv-290 was turned on and off repeatedly. The pcf-h290i was applied lateral stress to the scope connector. The log data of the cv-290 was confirmed. ("e216" scope communication error occurred. ) omsc performed an investigation on the actual clv-290sl. The reported phenomenon was not reproduced. The root cause of this phenomenon could not be conclusively determined. There is a possibility that temporary communication failure between the subject cv-290 and the pcf-h290i occurred, resulting malfunction of the endoscope image.
 
Manufacturer Narrative
This is a supplemental report for mfr report #8010047-2018¿00650. The subject clv-290sl was returned to olympus medical systems corp. (omsc). Functional checks were performed with the subject clv-290sl (sn (b)(4)) which was connected to cv-290 (sn (b)(4)) that was used when the reported defect occurred, pcf-hq290i (omsc asset) and oev262h (omsc asset). As a result, the reported defect was not reproduced. Any other defects did not occur either and the system of the device and omsc assets including the subject clv-290sl worked correctly. The subject clv-290sl conformed to the specifications. The investigation of the subject clv-290sl confirmed the following details: no abnormality was found from the observation of the outer appearance. No abnormality was found from the observation of the connector in the rear panel. The software was the latest version. The operation records were reviewed to confirm that there were no errors. No abnormality was found in the subject clv-290sl when it was operated in the system stated above. Omsc performed an investigation on the actual clv-290sl. The reported phenomenon was not reproduced. The root cause of this phenomenon could not be conclusively determined. An investigation is to be planned for the system consisted of the subject clv-290sl, the subject cv-290 (sn (b)(4)) and an endoscope pcf-h290i (sn (b)(4)) that was used in the reported complaint. We will conduct the investigation as soon as we receive the endoscope pcf-h290i (sn (b)(4)). No further information has been available. If we received any additional information, a supplement report will be submitted.
 
Manufacturer Narrative
This supplemental report is submitting to correct "device product code".
 
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Brand NameEVIS LUCERA 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 Key7431893
MDR Text Key106023293
Report Number8010047-2018-00650
Device Sequence Number1
Product Code GCT
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Type of Report Initial,Followup,Followup,Followup
Report Date 03/15/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/15/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberCLV-290SL
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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