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

Model Number CLV-190

Device Problem Contamination /Decontamination Problem (2895)

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

Event Date 05/27/2021

Event Type  malfunction  

Manufacturer Narrative

The device was evaluated by olympus and fluid invasion was noted in the air tubing.The investigation is ongoing and the root cause of the reported event cannot be determined at this time.If additional information becomes available, this report will be supplemented accordingly.

Event Description

A user facility returned the olympus, clv-190, evis exera iii xenon light source to olympus for repair due to a report of a broken socket.Upon inspection and testing of the returned unit by olympus, fluid invasion was found in the air tubing.This report is submitted for the malfunction of fluid invasion in the air tubing.As this was found during in-house service, there was no patient involvement.

Manufacturer Narrative

The legal manufacturer performed the device history records for this device and all records indicated that the product was manufactured according to all applicable procedures and met final product release criteria.No abnormalities were found.The investigation was completed by the legal manufacturer and determined that there is no manufacturing, material or processing related cause for this failure mode.Based on the evaluation, the fluid invasion inside the air tubing may have occurred due to a failure of the valve of the air supply / water supply mechanism of the equipment or a failure of the valve of the air supply / water supply mechanism of the scope.The legal manufacturer has determined that since it has been about 8 years since the date of manufacturer/delivery, the valve failure of the air supply / water supply mechanism may have been caused by age-deterioration or wear from long-term use.The legal manufacturer will continue to monitor the 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: 12160113
• MDR Text Key: 264139417
• Report Number: 8010047-2021-08817
• 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: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 07/28/2021

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 Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/21/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/21/2021
• Initial Date FDA Received: 07/13/2021
• Supplement Dates Manufacturer Received: 07/20/2021
• Supplement Dates FDA Received: 07/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1