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

Model Number CLV-180

Device Problem Output below Specifications (3004)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Due diligence was executed for this event.Event date is unknown.The device has been returned and a device evaluation completed for it.The device manufacture date is not available at this time.Low light of the device was confirmed.Upon inspection, it was observed that the device had a non-olympus lamp which was out of specification.In addition, it was noted that there was a worn out scope socket which caused poor connection.There was normal wear on housing.Based on the evaluation, the low light was attributed to non-olympus lamp.

Event Description

As reported for this event, the device had low light output.No reported patient involvement.

Manufacturer Narrative

There is more information on the device evaluation.This supplemental report is being submitted to provide this information.The device history record review confirmed that device there were no abnormalities, special adoption, or variations in manufacturing.Upon inspection, it was confirmed that the customer was using a non-olympus lamp for the device.The lamp was burnt out and out of specification giving a low light output.In addition, the worn scope socket is causing poor connection.The lamp being used was not specified by olympus for usage with the device.

• Brand Name: EVIS EXERA II 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: 10040690
• MDR Text Key: 190996690
• Report Number: 8010047-2020-02574
• 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: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 10/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/08/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: CLV-180
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/15/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1