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

Model Number CLV-190

Device Problem Infusion or Flow Problem (2964)

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

Event Date 12/07/2021

Event Type  malfunction  

Manufacturer Narrative

The evaluation confirmed the customer reported air intermittent is due to the device air tubing being full of blue liquid.Additionally, there is bue liquid inside pins of connector socket, the front panel is damaged and the lamp is non olympus.The investigation is ongoing; therefore, the root cause of the reported issue cannot be determined at this time.However, if additional information becomes available a follow up medical device report will be supplemented accordingly.

Event Description

The olympus (oci) was informed by the nurse at the user facility that the customer evis exera iii xenon light source was returned to the service center for a reported "air intermittent" that occurred during the middle of a enteroscopy procedure.The procedure was completed successfully with a similar device.The device was inspected prior to the procedure with no anomalies noted.During inspection and testing, foreign blue liquid was found inside the air tube and air pump of the light source.No patient injury or harm was reported to olympus.

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.It has been over 10 years since the subject device was manufactured.Based on the results of the investigation, a definitive root cause could not be established.The cause of the phenomenon was attributed to liquid invasion into the air tube, but the cause of the liquid invasion could not be further determined.Blue liquid was confirmed via inspection report within the air tube and on the pins of the connector socket.The instructions for use (ifu) state the following on prevention of the suggested phenomenon: ·if fluids are spilled on or into the light source, stop operation of the light source immediately and contact olympus.·do not apply excessive force to the light source and/or other instruments connected.Otherwise, damage and/or malfunction can occur.·always use the examination lamp [xenon lamp maj-1817].To order a new examination lamp, contact olympus.Olympus will continue to monitor field performance for 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
• Manufacturer Contact: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 13262018
• MDR Text Key: 295257250
• Report Number: 8010047-2022-01502
• Device Sequence Number: 1
• Product Code: NWB
• UDI-Device Identifier: 04953170298868
• UDI-Public: 04953170298868
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: CLASS2-EXMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 02/23/2022

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: 12/15/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/17/2021
• Initial Date FDA Received: 01/14/2022
• Supplement Dates Manufacturer Received: 01/31/2022
• Supplement Dates FDA Received: 02/23/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/05/2012
• 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