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

Model Number CLV-190

Device Problem Use of Device Problem (1670)

Patient Problem No Patient Involvement (2645)

Event Date 07/02/2020

Event Type  malfunction  

Manufacturer Narrative

The device was returned to olympus for evaluation.The device was visually inspected and minor cosmetic wear and tear was identified.The reported event could not be duplicated.The cause of the reported event cannot be determined at this time.If additional information becomes available at a later time, this report will be supplemented.

Event Description

It was reported that during maintenance/preparation for use the lights of the front panel of the unit were found to be flashing.The customer declined troubleshooting with technical assistance as per the customer troubleshooting had already been attempted to no avail.

Manufacturer Narrative

This report is being supplemented to provide the legal manufacturer¿s investigation summary regarding this report.The root cause could not be identified.The cause of the customer's experience is presumed based on the investigation result: since no error occurred during repair (user's experience could not be duplicated), it is presumed that rotation or driving operation of the turret or the rgb filter was unstable due to temporary accidental failure, resulting in occurrence of error (blinking of the indicators on the panel).

• 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: 10335080
• MDR Text Key: 200698019
• Report Number: 8010047-2020-04917
• 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,user f
• Type of Report: Initial,Followup
• Report Date: 10/22/2020

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: Health Professional
• Device Model Number: CLV-190
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/07/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/02/2020
• Initial Date FDA Received: 07/28/2020
• Supplement Dates Manufacturer Received: 09/22/2020
• Supplement Dates FDA Received: 10/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1