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

Model Number CLV-190

Device Problems Electrical Power Problem (2925); Excessive Heating (4030)

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

Event Date 02/07/2024

Event Type  malfunction  

Manufacturer Narrative

Olympus technician visited the site on feb 2, 2024 stating that the device was used in combination with cv-190 eu-me2 and the technician found that the overtemperature occurred due to poor ventilation caused by dust, the device was powered down and the emergency lamp took over.The device was cleaned and the temperature switch and sensor were check and confirmed to be working properly.There will be no product return.Should additional relevant information become available, a supplemental report will be submitted.Reviewer: takashi suzuki.Review result: acceptable.

Event Description

It was reported, the light source displayed error code e101 ¿ lamp temperature error.The issue occurred during an unknown procedure.There were no reports of patient harm.The customer also reported that this issue occurred two times and therefore two related records were created to capture these two events.C24058471 and c24057685.

Manufacturer Narrative

This supplemental report is being submitted to provide the results of the legal manufacturer's final investigation.The customer's complaint/reportable malfunction was confirmed.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over eleven (11) years since the subject device was manufactured.Based on the results of the investigation, a definitive root cause could not be determined.However, it is likely that the e101 error message, the device being powered down, and the emergency lamp taking over were due to poor ventilation caused by dust.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: 18793095
• MDR Text Key: 337512902
• Report Number: 3002808148-2024-01840
• Device Sequence Number: 1
• Product Code: NWB
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K131780
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/21/2024

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?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/07/2024
• Initial Date FDA Received: 02/27/2024
• Supplement Dates Manufacturer Received: 03/13/2024
• Supplement Dates FDA Received: 03/21/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/17/2012
• 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
• Treatment: CV-190 EU-ME2