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

Model Number CLV-190

Device Problems Loss of Power (1475); Intermittent Loss of Power (4016)

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

Event Date 08/14/2023

Event Type  malfunction  

Manufacturer Narrative

The device was returned to olympus and evaluated.The customer allegation could not be confirmed.The unit did not power off during the burn-in testing and functioned properly according to the technical guide.It was noted that the device had minor cosmetic wear and tear.The investigation is ongoing.Additional information was requested regarding the event; however the customer responded that the requested information is unknown.A supplemental report will be submitted upon completion of investigation or if any additional information is provided by the user facility.

Event Description

The customer reported to olympus, the evis exera iii xenon light source shut down during a diagnostic procedure.There were no reports of patient harm associated with the event.

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 specific cause of phenomenon could not be identified as the reported issue was not reproduced during evaluation.Olympus will continue to monitor field performance for this device.

Manufacturer Narrative

This supplemental report is being submitted to provide corrections for the initial mdr corrected fields: h6: medical device problem 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: 17698628
• MDR Text Key: 322833407
• Report Number: 3002808148-2023-09505
• 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,Followup,Followup
• Report Date: 10/25/2023

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: 08/18/2023
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/15/2023
• Initial Date FDA Received: 09/07/2023
• Supplement Dates Manufacturer Received: 10/06/2023; 10/17/2023
• Supplement Dates FDA Received: 10/11/2023; 10/25/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/06/2018
• 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