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

Model Number CLV-S40

Device Problem Intermittent Communication Failure (4038)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/09/2020

Event Type  malfunction  

Manufacturer Narrative

A review of the service history records indicated the light source has had no service records.The light source was purchased on may 31, 2004.The light source was not returned to the service center for evaluation, however, the investigation is ongoing.If additional information becomes available, this report will be supplemented accordingly.

Event Description

The service center was informed by the user facility that during the middle of a diagnostic cystoscopy procedure, the visera xenon light source worked intermittently as one minute the light source would work and the next it would not.There was no delay in the procedure as the procedure was completed with an alternate light source.No other devices were replaced.There was no patient injury reported.

Manufacturer Narrative

This supplemental report was submitted to provide additional information from the original equipment manufacturer (oem) for mdr# 8010047-2020-05296.No device was returned.The oem performed a device history record review and no abnormality was found.The oem completed the investigation and determined that there was no manufacturing, material or processing related cause for this failure mode.Based on the investigation results, the oem determined the likely cause of the intermittent image is that the device had been produced for more than 16 years, and that intermittent unstable luminescence of the lamp caused by degradation of the light-emitting control components due to long-term use resulted in intermittent events of the image.The device was purchased on may 31, 2004 with no repair records.Olympus will continue to monitor complaints for this device.

• Brand Name: VISERA 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: 10367836
• MDR Text Key: 202268342
• Report Number: 8010047-2020-05296
• 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,user f
• Type of Report: Initial,Followup
• Report Date: 01/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/05/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: CLV-S40
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1