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

Model Number CLV-190

Device Problem Electrical /Electronic Property Problem (1198)

Patient Problem No Information (3190)

Event Date 06/19/2020

Event Type  malfunction  

Manufacturer Narrative

The technical assistance center at olympus instructed the customer to return the device to olympus for evaluation.The device has yet to be returned to olympus.Multiple documented attempts have been made to obtain additional information regarding any potential patient impact.If additional information is received and/or the device is returned to olympus, a supplemental report will be submitted, as applicable.

Event Description

A biomedical engineer from the user facility reported the front panel lights were flashing on a clv-190 light source when the scope was not attached.Once the scope was attached, the system reportedly functioned as expected.There was no patient harm or injury reported.

Manufacturer Narrative

This report is being supplemented based on additional information provided by the legal manufacturer¿s investigation.The legal manufacturer cannot conclusively determine the cause of the user¿s experience, but they presumed that the device in question had passed about 7 years since its manufacturing, and that it was an event in which the internal board deteriorated and broke down due to aging caused by repeated use for a long period of time.It is assumed that the internal board could not be started properly, and that the device concerned was judged to be a main body malfunction, and the front panel blinked.A review of the dhr found no abnormality during the manufacturing of the device.The device instrument history was reviewed and showed that the device was purchased by the user facility on april 27, 2013 and the device has not yet been returned to olympus for service.

• 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: 10982190
• MDR Text Key: 227200491
• Report Number: 8010047-2020-10175
• Device Sequence Number: 1
• Product Code: NWB
• UDI-Device Identifier: 04953170298868
• UDI-Public: 04953170298868
• 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: 01/28/2021

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 the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/19/2020
• Initial Date FDA Received: 12/10/2020
• Supplement Dates Manufacturer Received: 01/06/2021
• Supplement Dates FDA Received: 01/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1