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

Model Number CLV-190

Device Problem Use of Device Problem (1670)

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

Event Type  malfunction  

Event Description

As reported, an error 204 focus error showed up as soon as system is powered up.The issue found at preparation for use.There is no patient involvement associated on this reported event.No user injury reported.Device evaluation found the illumination light was not emitted from the device due to use of olympus non-designated lamp.

Manufacturer Narrative

Device inspection found the illumination of light was not emitted from the device due to the use of olympus non-designated lamps.Investigation is ongoing.This report will be submitted accordingly following investigation.Investigation activities have been opened to manage the actions related to this issue and any required mdr reporting.¿.

Manufacturer Narrative

This report is being supplemented, to provide additional information, based on the legal manufacturer's final investigation, and to correct information provided on the initial report.The following sections were corrected: g2.A review of the device history record found no deviations, that could have caused or contributed to the reported issue.Based on the results of the legal manufacturer's investigation, the following device issues were confirmed.¿error 204, focus error immediately after the system start-up¿ and ¿use of a non-olympus lamp¿.However, a root cause could not be identified.It appears, that a user inadvertently installed a lamp, that is not designated by olympus.And against instructions for use (ifu).The instruction manual identifies, the following related verbiage: ¿chapter 6 lamp replacement.6.1 replacement of the examination (xenon) lamp.Always use the examination lamp designated below.To order a new examination lamp, contact olympus xenon lamp (b)(4)¿.Olympus will continue to monitor field performance for this device.

• Brand Name: EVIS EXERA III 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: 13246103
• MDR Text Key: 294236985
• Report Number: 8010047-2022-01379
• Device Sequence Number: 1
• Product Code: NWB
• UDI-Device Identifier: 04953170298868
• UDI-Public: 04953170298868
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: CLASS2-EXMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/13/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CLV-190
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/18/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/20/2014
• 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