MAUDE Adverse Event Report: SHIRAKAWA OLYMPUS CO., LTD. EVIS EXERA III XENON LIGHT SOURCE

Model Number CLV-190

Device Problem Electrical /Electronic Property Problem (1198)

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

Event Date 12/07/2023

Event Type  malfunction  

Manufacturer Narrative

The device was returned for evaluation.Inspection and testing found that during start-up there was a smoking smell and sparks due to a faulty ac/dc power supply.Additionally, the exhaust fan in the ventilation system was not functioning properly, there was dust build up and foreign material inside the fan and power supply.Based on the facts obtained in the investigation, it is likely that dust had accumulated in the power supply unit and fan, which temporarily ignited the dust when the power was turned on, causing sparks and smoke at the same time.From this, it is presumed that the power supply unit and fan failed due to the influence of dust.However, a definitive root cause could not be determined.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 8 years since the subject device was manufactured.Olympus will continue to monitor field performance for this device.

Event Description

The customer reported that during preparation for a diagnostic colonoscopy, the light source generated smoke and sparks on start-up.There was an approximate five-minute delay in the procedure to switch out the light source with another light source.There was no patient or user harm associated with the event.

• 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 961-8 061; JA 961-8061
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 18385838
• MDR Text Key: 331484648
• Report Number: 3002808148-2023-14731
• Device Sequence Number: 1
• Product Code: NWB
• UDI-Device Identifier: 04953170298622
• UDI-Public: 04953170298622
• 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: Health Professional,User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 12/22/2023

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: 12/08/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/07/2023
• Initial Date FDA Received: 12/22/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/08/2015
• 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