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

Model Number CLV-190

Device Problems Output Problem (3005); Appropriate Term/Code Not Available (3191)

Patient Problem No Patient Involvement (2645)

Event Date 07/07/2020

Event Type  malfunction  

Manufacturer Narrative

Due diligence has been executed for this event.No additional information of the event is available as yet.The device is not returned, as such a definitive root cause of the reported complaint cannot be determined at this time.Supplemental report(s) will be filed as the information becomes available.

Event Description

As reported for this event, the device lamp went out and did not light.There was no reported patient involvement.

Manufacturer Narrative

The device is not returned.As such, an actual device evaluation is not performed.An evaluation is done based on historical records.This supplemental report is being submitted to provide this information.Please see the updates in sections: g4, g7, h2, h3, h4, h6, and h10.The device history record review confirmed that device has no abnormalities, special adoption, or variations in manufacturing.Reported issue for the device is main lamp is not lighted.Since device is not returned and additional information not provided by customer, root cause could not be identified.The device has been in operation for more than five years, and it is likely that lamp life or igniter malfunction occurred due to long-term use.

• 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: 10339650
• MDR Text Key: 200846769
• Report Number: 8010047-2020-04970
• 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: other,user facility
• Type of Report: Initial,Followup
• Report Date: 12/09/2020

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: No Information
• Device Model Number: CLV-190
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/07/2020
• Initial Date FDA Received: 07/29/2020
• Supplement Dates Manufacturer Received: 11/16/2020
• Supplement Dates FDA Received: 12/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1