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

Model Number CLV-190

Device Problem Installation-Related Problem (2965)

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

Event Type  malfunction  

Event Description

While inspecting a returned olympus evis exera iii xenon light source loaner device, it was discovered that the heat sink had been incorrectly installed.There was no patient involvement during this event.

Manufacturer Narrative

The device was returned, and an initial evaluation was conducted by olympus; however, investigation is ongoing.During the initial evaluation, the heatsink assembly had been incorrectly installed.Additionally, the lamp provided a life meter reading of 100+ hours.The top cover was bent, and the front panel was discolored, and the chassis was found rusted.If additional information becomes available following the device evaluation, a supplemental report will be filed.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.Please see the updates in sections h6 and h10.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 10 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 the heatsink assembly was rusted due to inappropriate heat sink installation.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: 15968887
• MDR Text Key: 308150595
• Report Number: 3002808148-2022-05162
• 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: CLASS2-EXMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 02/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2022
• 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: 11/23/2022
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/19/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/11/2012
• 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