MAUDE Adverse Event Report: SHIRAKAWA OLYMPUS CO., LTD. VISERA 4K UHD XENON LIGHT SOURCE

Model Number CLV-S400

Device Problem Loss of Power (1475)

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

Event Date 07/21/2023

Event Type  malfunction  

Event Description

The customer reported to olympus that the visera 4k uhd xenon light source had no power/intermittent power.When it's on startup, it will run for a little bit, then just power off. the issue was found during preparation for the use of an unspecified diagnostic procedure.No additional information is available.There were no reports of patient harm.

Manufacturer Narrative

The device was returned to olympus for evaluation, and the customer's allegation was not confirmed.The device evaluation found the igniter was firing normally, and the power switch was working okay.The device was turned on and off several times without any issues.The device evaluation also found a worn-out socket slider switch, causing intermittent use of high intensity mode; the olympus lamp life meter was reading below 50 hours, and the unstable light intensity output measured out of range. minor scratches on the front panel and top cover.  the investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.

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 investigation, the root cause was unable to be determined for the reportable event of the power turning off.Olympus will continue to monitor field performance for this device.

• Brand Name: VISERA 4K UHD 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: 17619875
• MDR Text Key: 321937165
• Report Number: 3002808148-2023-08921
• Device Sequence Number: 1
• Product Code: NWB
• UDI-Device Identifier: 04953170374579
• UDI-Public: 04953170374579
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K151011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/27/2023

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-S400
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/03/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/24/2023
• Supplement Dates Manufacturer Received: 10/27/2023
• Supplement Dates FDA Received: 10/27/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/22/2018
• 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