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

Model Number CLV-180

Device Problems Electrical /Electronic Property Problem (1198); Defective Device (2588)

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

Event Date 07/14/2021

Event Type  malfunction  

Manufacturer Narrative

The returned device was evaluated.Inspection found charred fuse component inside ac inlet of power supply that indicated bad power supply.Additionally, the olympus lamp life meter noted to be reading at 100+hours, light output measured within specification.Igniter and iris cable are up to date.Fan and air pressure both tested and functional.Based on evaluation findings the reported issue was identified to be due to charred fuse component inside the ac inlet of power supply indicating a bad power supply.Investigation is ongoing.This report will be supplemented accordingly following investigation.

Event Description

As reported, the piece of the cyf-v2 of the light guide cable is stuck in the unit.The issue occurred during an unknown event.There is no patient involvement on this reported event.No user injury reported.Device evaluation found charred fuse component inside ac inlet of power supply that indicated bad power supply.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's investigation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.All records indicated that the product was manufactured according to all applicable procedures and met final product release criteria.No abnormalities were found.Based on the results of the investigation, user may have applied excessive force obliquely to the light guide when connecting/disconnecting, the guide connector of cyf-v2 was damaged and stuck in the unit.The charred fuse may be attributed to aging from long-term repeated use, as the subject device was purchased more than 8 years ago.Descriptions were found on handling in the ifu (instruction for use) , the user manual states.Following this could prevent the phenomenon (damaged connector) to occur.Never apply excessive force to connectors.This could damage the connectors.Olympus will continue to monitor complaints for this device.

• Brand Name: EVIS EXERA II 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: 12418504
• MDR Text Key: 273829700
• Report Number: 8010047-2021-11180
• Device Sequence Number: 1
• Product Code: NWB
• UDI-Device Identifier: 04953170215544
• UDI-Public: 04953170215544
• 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,user f
• Type of Report: Initial,Followup
• Report Date: 09/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/02/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CLV-180
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/11/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CYF-V2 SCOPE