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

Model Number CLV-180

Device Problems Insufficient Cooling (1130); Display or Visual Feedback Problem (1184); Loss of Power (1475)

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

Event Date 04/09/2021

Event Type  malfunction  

Manufacturer Narrative

The suspect device was returned to olympus and evaluated.The reported problem of "cooling fan was not functioning" could not be confirmed; the cooling fan was verified to function as intended.The reported problems of main lamp went out and loss of power were confirmed; the main lamp was found burned out and a faulty power supply was found, preventing the unit from powering up.The investigation is ongoing and the root cause of the reported event cannot be determined at this time.If additional information becomes available, this report will be supplemented accordingly.

Event Description

A user facility reported to olympus that the main lamp went out and the spare lamp ignited during a procedure and while troubleshooting the problem at a later time, power was lost completely.In addition, it was reported that the cooling fan was not functioning.The intended procedure was completed using the same device.There was no patient injury, associated with the problem, reported to olympus.This is report 1 of 2.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.Based on the results of the investigation, and the phenomenon not duplicated at the repair department, since the malfunction of the power circuit was confirmed, we surmised that the cooling fan did not work due to the following reason.It has been more than 11 years since the subject device was installed, so aging deterioration occurred in the power circuit due to long-term usage leading to the spare lamp lit because the xenon lamp could not be lit because of the damage.The glass of the lamp was cracked and gas was leaking therefore it is likely that a strong external force was applied to the housing by dropping it so the lamp was damaged.Olympus will continue to monitor the field performance of 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: 11806678
• MDR Text Key: 250369858
• Report Number: 8010047-2021-06142
• Device Sequence Number: 1
• Product Code: NWB
• UDI-Device Identifier: 04953170216961
• UDI-Public: 04953170216961
• 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: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 09/21/2021

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: Health Professional
• Device Model Number: CLV-180
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/20/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/12/2021
• Initial Date FDA Received: 05/11/2021
• Supplement Dates Manufacturer Received: 09/07/2021
• Supplement Dates FDA Received: 09/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1