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

Model Number CLV-190

Device Problems Defective Device (2588); Power Problem (3010)

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

Event Type  malfunction  

Manufacturer Narrative

The returned device was evaluated.The customer reported issue was confirmed.The device main switch was observed to be damaged and needs to be upgraded.Worn out scope socket slider switch causing intermittent use of high intensity mode was observed.Corrosion in air tubing was also noted.Lamp hours were noted to be at 100+ plus hours and light output was noted to be within specifications.Unit was noted to be equipped with new type switch.Based on evaluation findings the reported issue was found to be due to damaged main switch attributed to component failure.The investigation is ongoing.This report will be supplemented accordingly following investigations.This mdr is being submitted retrospectively as part of a remediation effort related to the recent system and process changes.A capa has been opened to manage the actions related to remediation of this issue and any required reporting.

Event Description

It was reported that the device power button is stuck, pushed in, the power is off.The issue occurred during preparation for use.There was no patient involvement, no user injury reported due to the event.

Event Description

Updates from the customer regarding the event reported: the problem was found during preparation for a colonoscopy procedure.The same kind of machine was used to complete the procedure.

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, from the date of manufacture (october 1, 2013), it was presumed that the power switch was damaged due to the amount of operating force applied to the power switch and the number of times that the power switch was exceeded the assumed value due to the product was a product prior to countermeasures due to a change in the power switch design.It was confirmed that the design was changed as a resistance improvement of the power switch damage.Countermeasures item was shipped after november 26, 2013.The operating environment is described below in the instruction manual or ifu (instruction for use).Use the light source only under the conditions described in, transportation, storage, and operating environments on page 109 and, specifications on page 109 in the appendix.Olympus will continue to monitor complaints 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
• MDR Report Key: 12011220
• MDR Text Key: 269765004
• Report Number: 8010047-2021-07614
• Device Sequence Number: 1
• Product Code: NWB
• UDI-Device Identifier: 04953170298868
• UDI-Public: 04953170298868
• 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: 07/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/16/2021
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/20/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1