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

Model Number CLV-190

Device Problem Intermittent Loss of Power (4016)

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

Event Date 04/16/2024

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that there was intermittent power, while using the lightsource.There was no patient harm associated with the event.

Manufacturer Narrative

This supplemental report is being submitted to provide the results of 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.It has been over 6 years, since the subject device was manufactured.Based on the results of the investigation.A definitive root cause could not be determined, since the device was not returned for device evaluation.Olympus will continue to monitor field performance for this device. .

Event Description

It was reported, that the light source was shutting off.The issue occurred, during a procedure.There was no patient harm associated with the event.Additional information received, from the customer.Reported, that they discovered there was a loose wire.And the device was now working.

• 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: 19168757
• MDR Text Key: 340928365
• Report Number: 3002808148-2024-03787
• 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
• Report Date: 04/23/2024

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
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/16/2024
• Initial Date FDA Received: 04/23/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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