MAUDE Adverse Event Report: SHIRAKAWA OLYMPUS CO., LTD. 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 Date 08/31/2023

Event Type  malfunction  

Event Description

The customer reported to olympus that the evis exera iii light source had water invasion.The issue was found during an unknown procedure.There were no reports of patient harm associated with the event.

Manufacturer Narrative

The device was returned and the customer allegation was confirmed.The device had signs of fluid invasion.The pins on the scope socket were corroded.When the unit was powered on, the b30 error was displayed intermittently.Cosmetic damage was noted.There were fine cracks in the front panel at the bottom of scope socket area and the caution label was worn.The investigation is ongoing and follow-up with the user facility is currently being performed.A supplemental report will be submitted on completion of investigation or if any additional information is provided by the user facility.

Manufacturer Narrative

This report is being submitted for update to b5 and h6 based on the additional information received from the customer.Information regarding when the issue occurred has been corrected in b5 based on the new information received.

Event Description

The customer further reported that the problem occurred during preparation for use for a procedure.The patient was not in the room.The intended procedure was completed with a similar device.There was an error message displayed; however the customer was unsure of the error message.There was no patient involvement.

Manufacturer Narrative

This supplemental report is being submitted to provide the results of the legal manufacturer's final investigation.New information added to the following fields: h6.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over seven (7) years since the subject device was manufactured.Based on the results of the investigation, it is likely the following led to the malfunction: there was signs of fluid invasion and the was found fluid adhered to the electrical contacts of the scope socket.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): SHIRAKAWA OLYMPUS CO., LTD.; 3-1 okamiyama; odakura, nishigo-mura,; nishishirakawa-gun, fukushima 961-8 061; JA 961-8061
• Manufacturer (Section G): SHIRAKAWA OLYMPUS CO., LTD.; 3-1 okamiyama; odakura, nishigo-mura,; nishishirakawa-gun, fukushima
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 17743923
• MDR Text Key: 323379663
• Report Number: 3002808148-2023-09826
• Device Sequence Number: 1
• Product Code: NWB
• UDI-Device Identifier: 04953170298868
• UDI-Public: 04953170298868
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131780
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup,Followup
• Report Date: 11/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2023
• 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: 09/06/2023
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/14/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/29/2016
• 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