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

Model Number CLV-190

Device Problems Electrical /Electronic Property Problem (1198); Environmental Particulates (2930); Excessive Heating (4030)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

The device has not been returned to omsc but was returned to olympus repair center for evaluation.Olympus repair center inspected the device and confirmed the following; the reported phenomenon that the examination lamp went off and the emergency lamp worked was reproduced.The inside of the device and the optics were very dusty and the ventilation grills and fan blades were heavily clogged with dust.The device was a third-party lamp installed and the examination lamp was not installed correctly.And the screw on the device was loose.The examination lamp was loosely screwed into the heat sink.There were some cracks in the video connector socket.The hoses for conducting air were contaminated with liquid.The exact cause of the reported event could not be conclusively determined at this time.If additional information becomes available, this report will be supplemented.

Event Description

Olympus medical systems corp.(omsc) was informed by the user that during the receipt inspection, after changing the examination lamp twice, the examination lamp was not ignited and the device automatically turned off.And the emergency lamp worked, and clv temperature error e101 and clv lamp error e102 occurred.Error e101 means that the temperature inside of the light source has increased and the safety mechanism is working.Error e102 means that the light source has broken down.There was no report of patient injury associated with the event.Olympus inspected the device at olympus repair center and found that the following; the inside of the device was very dusty, so that there was not enough cooling air for the examination lamp and the examination lamp went off when it overheated.The heat compound was applied so excessive to the lamp.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information.The exact cause of the reported event could not be conclusively determined, because the device has not been returned to olympus medical systems corp.(omsc).However, there is possibility that the heat compound was applied so excessive to the lamp, because the user did not wipe off the old heat compound sufficiently when replacing the examination lamp and applied additional heat compound.In addition, the clv lamp error e102 may have occurred because the temperature inside the device rose and the examination lamp went off due to the following causes: -the fan failed due to deterioration due to repeated use for a long period of time, because more than 7 years have passed since the device was manufactured.-the user used the device in a dusty environment and did not maintain the device, causing heavy dust to build up inside the device and block the ventilation grills.The temperature switch may have been activated due to an increase in the temperature inside the device, resulting in clv temperature error e101.The instruction manual provides preventive measures against the reported failure mode.Device history record (dhr) review indicates that the product was manufactured and tested in accordance with all applicable procedures and met all final product release criteria.If additional information becomes available, this report will be supplemented.

• 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: 11458336
• MDR Text Key: 239496730
• Report Number: 8010047-2021-03568
• 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: foreign,user facility
• Type of Report: Initial,Followup
• Report Date: 04/20/2021

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: No Information
• Device Model Number: CLV-190
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/15/2021
• Initial Date FDA Received: 03/11/2021
• Supplement Dates Manufacturer Received: 03/25/2021
• Supplement Dates FDA Received: 04/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1