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

Model Number CLV-190

Device Problem Output below Specifications (3004)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

The asset unit was returned to the service center.A physical evaluation was performed and a third party lamp was found installed in the asset light source and the lamp life read 410+ hours.Additionally, the locking mechanism of the scope connector socket was worn out.To mitigate device damage, the instruction manual provides warning which states, "never install a lamp that has not been approved by olympus.The use of a non-approved lamp can cause damage to the light source and ancillary equipment, malfunction or a fire".

Event Description

The service center became aware that the xenon light source asset unit was found to have a third party lamp installed.There was no patient involvement reported.

Manufacturer Narrative

This supplemental report was submitted to provide additional information to mdr# 8010047-2020-02806.The original equipment manufacturer (oem) performed a device history record review and no abnormalities were noted.An investigation was completed by the oem and determined that there is no manufacturing, material or processing related cause for this failure mode.The potential root cause has been determined to be due to the user did not notice (or ignored) the commentary and has attached the desired lamp (non-designated product.Olympus will continue to monitor the field performance of this device.The appendix ¿ combination equipment in the instructions for use states, "if combinations of equipment other than those shown below are used, the full responsibility is assumed by the medical treatment facility.".

• 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: 10075063
• MDR Text Key: 208997263
• Report Number: 8010047-2020-02806
• Device Sequence Number: 1
• Product Code: NWB
• 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
• Type of Report: Initial,Followup
• Report Date: 12/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/20/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: CLV-190
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/20/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1