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

Model Number CLV-190

Device Problem Optical Problem (3001)

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

Event Date 08/10/2021

Event Type  malfunction  

Event Description

The customer reported that the live image goes totally black during an exam.It is unknown if the intended procedure was completed.There was no patient injury.

Manufacturer Narrative

As part of our investigation, the technical assistance center spoke with the customer regarding the issue.The customer stated they cleaned the unit¿s contacts and the issue reoccurred with multiple scope.Tac offered the customer the option to return the unit for repair.The unit was returned to the service center for evaluation.The customer¿s complaint of ¿ it was blacking out during cases¿ could not be confirmed.The unit¿s connections were inspected and found to be normal.The unit¿s lamp life read 415hours and 35 minutes.The cause of the reported event cannot be determined at this time.An investigation is ongoing to obtain additional information regarding the reported event.If additional information is received this report will be supplemented accordingly.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's investigation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.As a result of the legal manufacturer's investigation, since this was not reproduced by the repair division, it is assumed that there was no problem with the device concerned and the connection of the light source cable connecting cv-190,clv-190 and the video cable connecting cv-190 and the monitor was not perfect.In addition, since it has been confirmed that the light content of the ramp is below specification, it is speculated that a significant decrease in light content occurred temporarily and the images became darker.The instruction manual identifies the following verbiage, which may prevent the phenomenon: "properly and securely connect all cables.If the cable connector has connection screws, tighten up the screws.Otherwise, equipment damage or malfunction can result".Olympus will continue to monitor field performance of this device.

• 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: 12436858
• MDR Text Key: 281087467
• Report Number: 8010047-2021-11388
• Device Sequence Number: 1
• Product Code: NWB
• UDI-Device Identifier: 04953170298868
• UDI-Public: 04953170298868
• Combination Product (y/n): N
• PMA/PMN Number: 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: 10/21/2021

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 Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/16/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/10/2021
• Initial Date FDA Received: 09/07/2021
• Supplement Dates Manufacturer Received: 10/20/2021
• Supplement Dates FDA Received: 10/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1