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

Model Number CLV-190

Device Problems Defective Component (2292); Installation-Related Problem (2965)

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

Event Date 07/22/2021

Event Type  malfunction  

Manufacturer Narrative

The user facility returned the asset to the service center.The evaluation observed the manual high intensity is working intermittently due to a defective main pc board and the output socket was loose.The asset unit repair is in progress.The original equipment manufacturer¿s investigation is ongoing; therefore, the root cause of the reported issue/malfunction cannot be determined at this time.However, if additional information becomes available a follow up medical device report will be supplemented accordingly.

Event Description

The technical support engineer was informed by the endoscopy technician at the user facility that the "image was too bright" and "the main lamp went off" when inspecting/testing the asset evis exera ii xenon light source prior to any procedure.The endoscopy technician further reported the staff switched from auto to manual setting and dimmed the lamp down to correct the brightness issue.The intended procedure was completed using same device.No patient injury or harm was reported.Additionally, the staff observed light control cable was not properly attached in the back of the unit.The cable was uninstalled and then reinstalled appropriately which resolved the issue.

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 8 years since the subject device was manufactured.Based on the results of the investigation, the manual high intensity was working intermittently because the light source cable was improperly connected.Additionally, aging of the parts on the main board may have caused the failure.This issue is addressed in the instructions for use (ifu): "properly and securely connect all cables.If the cable connector has connection screws, tighten up the screws.Otherwise, equipment damage or malfunction can result." the lamp failure was attributed to the lamp exceeding the maximum hours and ended its life as the phenomenon was resolved with replacing it.Olympus will continue to monitor the field performance of 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: 12345159
• MDR Text Key: 267515209
• Report Number: 8010047-2021-10498
• 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,health
• Type of Report: Initial,Followup
• Report Date: 10/29/2021

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-190
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/29/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/22/2021
• Initial Date FDA Received: 08/19/2021
• Supplement Dates Manufacturer Received: 10/27/2021
• Supplement Dates FDA Received: 10/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1