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

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".

• Brand Name: EVIS LUCERA ELITE XENON LIGHT SOURCE
• Type of Device: XENON LIGHT SOURCE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to
• MDR Report Key: 7431893
• MDR Text Key: 106023293
• Report Number: 8010047-2018-00650
• Device Sequence Number: 1
• Product Code: GCT
• Combination Product (y/n): N
• Number of Events Reported: 1
• 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

1 Patient was Involved in the Event

• Date FDA Received: 04/15/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CLV-290SL
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/20/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1