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

Model Number CLV-260SL

Device Problem Erratic or Intermittent Display (1182)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/31/2019

Event Type  malfunction  

Manufacturer Narrative

The subject clv-260sl was not returned to olympus medical systems corp.(omsc).However, as a result of inspection by an olympus local engineer, no fault was found with the subject clv-260sl.Omsc has continued to investigate the subject clv-260sl to identify the root cause of this failure phenomenon.The clv-260sl 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

During a gastropexy, the endoscopic image on a monitor was flickering when the user connected the unspecified endoscope with the subject clv-260sl.The user replaced the subject clv-260sl with unspecified another device and completed the procedure.There was no report of the patient¿s injury regarding this event.However, the user took the subject clv-260sl out of use, because the same flickering endoscopic image issue occurred three times when using the subject clv-260sl in the past.

Manufacturer Narrative

Olympus medical systems corp.(omsc) received following additional information from user.-the user changed some settings when the user used the olympus endoscope system including the subject clv-260sl with unspecified third party unit.After that, the user possibly forgot to put it back to the original settings on the unspecified monitor.The subject clv-260sl was not returned to omsc.However, a local olympus service engineer inspected the olympus endoscope system including the subject clv-260sl again and no fault was found with them.Based on the investigation result so far, omsc concluded that there is no abnormality with the subject clv-260sl and the cause of this event was possibly attributed to that the user set inadequate setting on the unspecified monitor used with the subject clv-260.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" of common device name.

Manufacturer Narrative

Omsc checked the device history record of the subject clv-260sl, and there was no irregularity found.There were no further details provided.If significant additional information is received, this report will be supplemented.

• Brand Name: EVIS LUCERA 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: 8342165
• MDR Text Key: 139453711
• Report Number: 8010047-2019-01088
• 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: company representative,health
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CLV-260SL
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1