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

Model Number CLV-S190

Device Problem Use of Device Problem (1670)

Patient Problem No Patient Involvement (2645)

Event Date 06/10/2020

Event Type  malfunction  

Manufacturer Narrative

During troubleshooting, the sales representative indicated they will try to replace the main lamp light source to see if that resolves the issue.Tac recommended to send the light source in for repair but the sales representative chose to replace the xenon lamp first and then would sent to repairs if issue could not be resolved.As part of the investigation, olympus followed up with the sales representative to obtain additional information but no further information was obtained to date.The cause cannot be confirmed, however, the investigation is ongoing.If additional information becomes available, this report will be supplemented accordingly.

Event Description

The technical assistance center (tac) was informed by the sales rep representative that the viscera elite xenon light source remained in standby mode and the spare lamp indicator was activated.In addition, there were multiple errors that occurred with the light source.There was no patient involvement reported.

Manufacturer Narrative

This supplemental report was submitted to provide additional information to mdr# 8010047-2020-04164.An investigation was completed by the oem.However, the root cause of the reported event could not be conclusively determined no device was returned and insufficient information was reported.Based on the information available, the possible causes can be attributed to the following: since there was no problem with the replacement of the xenon lamp, it is inferred that the lamp was broken, which is the cause of the phenomenon.As for the cause, it is inferred that it occurred due to the accidental failure of the lamp, because it was shorter than usual for the usage time of the lamp.Olympus will continue to monitor the field performance of this device.

• Brand Name: VISERA ELITE XENON LIGHT SOURCE
• Type of Device: XENON LIGHT SOURCE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• MDR Report Key: 10260752
• MDR Text Key: 223651994
• Report Number: 8010047-2020-04164
• Device Sequence Number: 1
• Product Code: NWB
• Combination Product (y/n): N
• PMA/PMN Number: CLASS2-EXMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 10/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: CLV-S190
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/10/2020
• Initial Date FDA Received: 07/10/2020
• Supplement Dates Manufacturer Received: 10/05/2020
• Supplement Dates FDA Received: 10/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1