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

Model Number CLV-S40

Device Problem Defective Component (2292)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

The evaluation confirmed the reported "loud clicking noise when turned on¿ was due to a faulty fan.Additionally, the high intensity mode is not working due to a worn out scope socket and slider switch.The olympus lamp life meter is expired and the external housing was missing a side hook.The clv-s40 light source is discontinued from service and was returned to the customer unrepaired.A review of the repair history shows no previous repairs records; purchased on 22, march 2004.The investigation is ongoing; therefore, the root cause of the reported malfunction cannot be determined at this time.However, if additional information becomes available, this report will be supplemented accordingly.Investigation activities have been opened to manage the actions related to this late report and any required mdr reporting.

Event Description

The service center was informed by the user facility that the visera xenon light source had a "loud clicking noise when turned on" during preparation for use.The light source was returned and upon inspection/testing, the reported issue was confirmed as the light source was found to have a faulty fan malfunction.No patient involvement was reported.

Manufacturer Narrative

This supplemental report was submitted to provide additional information from the legal manufacturer.The legal manufacturer was unable to performed a review of the manufacturing records as the device was manufactured more than 15 years ago.A review of the complaint history shows no similar complaints.Additionally, no same or similar complaint has not been reported of the same device at the same facility.The investigation was completed by the legal manufacturer.The concerned device was not returned to the legal manufacturer for evaluation, therefore the exact cause of the reported malfunction could not be conclusively determined.However, since the device was manufactured more than 15 years ago, the potential cause of the reported malfunction is due to age deterioration.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: 12218575
• MDR Text Key: 267626326
• Report Number: 8010047-2021-09249
• Device Sequence Number: 1
• Product Code: GCT
• UDI-Device Identifier: 04953170228933
• UDI-Public: 04953170228933
• Combination Product (y/n): N
• PMA/PMN Number: K062049
• 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: 09/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/23/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CLV-S40
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/14/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1