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

Model Number CLV-180

Device Problem Failure to Power Up (1476)

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

Event Date 12/06/2021

Event Type  malfunction  

Manufacturer Narrative

The suspect device was returned to olympus and evaluated.The reported problem was not confirmed.However, a charred fuse component on the ac inlet of the power supply was found, indicative of a bad power supply.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 light source would not power on.The problem, as reported to olympus, was identified during preparation for use.The intended procedure was completed using a similar device.There was no delay in procedure associated with the reported problem.There was no patient injury, associated with the problem, reported to olympus.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 10 years since the subject device was manufactured.Based on the results of the investigation, a definitive root cause cannot be identified.Regarding the power cannot be turned on, it is unknown if the phenomenon occurred due to a malfunction of the subject device because the phenomenon was not reproduced in the repair department.Regarding the charred fuse component on the inlet of the power supply, the cause is unknown.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
• Manufacturer Contact: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 13114325
• MDR Text Key: 285178702
• Report Number: 8010047-2021-16954
• Device Sequence Number: 1
• Product Code: NWB
• UDI-Device Identifier: 04953170215544
• UDI-Public: 04953170215544
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: CLASS2-EXMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 02/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2021
• 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: 12/07/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/21/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/20/2011
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1