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

Model Number CLV-190

Device Problem Failure to Power Up (1476)

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

Event Type  malfunction  

Event Description

It was reported the xenon light source front panel switches are not functioning.The power button seems to be stuck.There were no reports of patient harm.

Manufacturer Narrative

The evaluation of the event is ongoing.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

Additional information was supplied by the customer in two separate emails, stating that this unit had been sitting around in the shop for about a year.Unfortunately, there is no one there to ask about it since it is so old.The event happened during an overnight check.No patient was involved.No error codes were reported.

Manufacturer Narrative

This supplemental report is being submitted to provide the results of the legal manufacturer's final investigation.Additional information added to field b5, d9, h3, h4, 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.The device was returned to olympus for inspection, and the customer's complaint of power button sticking was confirmed.Based on the results of the investigation, a definitive root cause cannot be determined.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: 19102192
• MDR Text Key: 340807639
• Report Number: 3002808148-2024-03476
• 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: Health Professional,User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 05/15/2024

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?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/04/2024
• Initial Date FDA Received: 04/12/2024
• Supplement Dates Manufacturer Received: 05/10/2024
• Supplement Dates FDA Received: 05/15/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/07/2016
• 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