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

Model Number CLV-190

Device Problem Moisture or Humidity Problem (2986)

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

Event Type  malfunction  

Event Description

The customer reported that during maintenance, a field service engineer observed moisture in the air hose of the evis exera iii xenon light source.There was no patient involvement, no harm or user injury reported due to the event.

Manufacturer Narrative

The field service engineer replaced the tube and support coil.The investigation is ongoing; therefore, the root cause of the reported event cannot be determined at this time, however, if additional information becomes available, this report will be supplemented accordingly.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Based on the results of the legal manufacturer's investigation, a root cause could not be identified.The customer replaced the gt348500 and gt348600 to prevent liquid invasion according to the field service engineer (fse).The cause of the reported event cannot be conclusively determined.Olympus will continue to monitor field performance for this device.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.It was confirmed that there was a liquid mark in the delivered air flow tube.There was indication of a mixture of nickel rust, thought to be derived from the spring in the tube, and vinyl chloride, which was thought to be the material of the tube.Additionally, a white powdery adherent was confirmed in a past complaint ((b)(4)).Based on the component analysis results, it was confirmed that the components detected in the mixture are a mixture of rust of the spring, which is considered to be derived from the spring in the tube, and vinyl chloride, which is considered to be the material of the tube.There were no manufacturing abnormalities or modifications.

• 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
• Manufacturer Contact: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 13506933
• MDR Text Key: 285470361
• Report Number: 8010047-2022-02741
• Device Sequence Number: 1
• Product Code: NWB
• UDI-Device Identifier: 04953170298868
• UDI-Public: 04953170298868
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: CLASS2-EXMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 05/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/10/2022
• 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?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/21/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1