MAUDE Adverse Event Report: SHIRAKAWA OLYMPUS CO., LTD. VISERA ELITE XENON LIGHT SOURCE

Model Number CLV-S190

Device Problem Device Emits Odor (1425)

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

Event Date 07/11/2022

Event Type  malfunction  

Manufacturer Narrative

The device was returned to olympus for evaluation and the customer¿s allegation was not confirmed.The evaluation uncovered the lock release was due to detection lever wear.There were no other abnormalities found.The investigation is ongoing; therefore, the root cause of the reported event cannot be determined at this time.However, if additional information becomes available this report will be supplemented.

Event Description

During an unknown procedure, the visera elite xenon light source generated a sound, and a burnt smell was detected without an error message being displayed.The procedure was completed using a similar device.There were no reports of patient harm associated with this event.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.It has been over 10 years since the subject device was manufactured.Based on the results of the legal manufacturer's investigation, a root cause could not be identified.The phenomenon was not reproduced.A review of the device history record found no deviations that could have caused or contributed to the reported issue.The cause of the reported event cannot be conclusively determined.Olympus will continue to monitor field performance for this device.

• Brand Name: VISERA ELITE 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 Contact: masaharu hirose ; 3-1 okamiyama; odakura, nishigo-mura,; nishishirakawa-gun, fukushima 961-8-061 ; JA 961-8061 ; 426422891
• MDR Report Key: 15176477
• MDR Text Key: 304963824
• Report Number: 3002808148-2022-00731
• Device Sequence Number: 1
• Product Code: NWB
• UDI-Device Identifier: 04953170301995
• UDI-Public: 04953170301995
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: CLASS2-EXMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 10/12/2022

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-S190
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/14/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/11/2022
• Initial Date FDA Received: 08/05/2022
• Supplement Dates Manufacturer Received: 09/14/2022
• Supplement Dates FDA Received: 10/12/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/10/2012
• 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