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

Model Number CLV-180

Device Problem Failure to Power Up (1476)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/14/2020

Event Type  malfunction  

Manufacturer Narrative

The device has not yet been returned for evaluation.If additional information becomes available following device evaluation, a supplemental report will be filed.

Event Description

The customer reported to olympus that during preparation for use, no power/intermittent power to device.There was no patient injury reported.

Manufacturer Narrative

This supplemental report was submitted to provide additional information to mdr# 8010047-2020-03158.A review of the instrument history shows the device was purchased on june 17, 2006 with no previous repair records.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.It is presumed that it has been more than 13 years old since the device was delivered; therefore, the potential root cause of the reported power failure has been determined to be due to the power supply unit (converter) failed due to the deterioration of the power supply components.Olympus will continue to monitor the field performance of this 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: 10124680
• MDR Text Key: 209394714
• Report Number: 8010047-2020-03158
• 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: 12/04/2020

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-180
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/13/2020
• Initial Date FDA Received: 06/05/2020
• Supplement Dates Manufacturer Received: 11/05/2020
• Supplement Dates FDA Received: 12/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1