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

Model Number CLV-190

Device Problems Corroded (1131); Poor Quality Image (1408); Naturally Worn (2988)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The device referenced in this report has returned to olympus for evaluation.The definitive cause of the customer's experience cannot be determined at this time.The investigation is ongoing.Physical evaluation of the complaint device reveals: the user's report is not confirmed.The olympus lamp has 200+ hours and the light output is below specifications.The housing has minor corrosion.The scope socket pins are corroded.The device has the new type switch.Air output is within specifications.This report will be updated upon completion of the investigation or upon receipt of additional relevant information.

Event Description

It is reported during an unspecified procedure using an evis exera iii xenon light source, the light doesn't adjust when you have it in auto, and the image gets very dark.When switched to manual mode, the image goes completely dark.There was no patient impact related to this occurrence.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.Multiple documented attempts to obtain additional information from the user facility have been unsuccessful, to-date.Based on the legal manufacturer's investigation, since the device was manufactured over eight years ago, it is likely the service life of the mains lamp has been exhausted due to repeated use for a long period of time.Since the spare lamp is lit, it is lower than when the main lamp is lit, and it is assumed that the dimming does not work and it is dark, contributing to the user's reported issue.The device history record (dhr) was reviewed and there were no problems found during the manufacturing of the device that would have caused or contributed to the reported issue.The device met all specifications at the time of shipment.

• 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: 11301991
• MDR Text Key: 233462283
• Report Number: 8010047-2021-02430
• 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: user facility
• Type of Report: Initial,Followup
• Report Date: 03/17/2021

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: 01/28/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/19/2021
• Initial Date FDA Received: 02/09/2021
• Supplement Dates Manufacturer Received: 03/11/2021
• Supplement Dates FDA Received: 03/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1