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

Model Number CLV-S190

Device Problem Optical Problem (3001)

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

Event Date 05/25/2023

Event Type  malfunction  

Event Description

A customer reported no light from the scope when connected to the visera elite xenon light source.There were no reports of patient harm.

Manufacturer Narrative

The device was returned to an olympus repair facility and an evaluation of the device was performed.Upon inspection and testing of the unit, the reported problem of no light from the scope could not be reproduced.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.

Manufacturer Narrative

Correction to the previous follow-up report as h4 was incorrectly corrected.The device manufacturer date is 08oct2013 from the initial medwatch.

Manufacturer Narrative

Correction: correcting h4 - manufacturer date from oct 8, 2913 to feb.25, 2021 this report is being supplemented to provide additional information based on the legal manufacturer's final investigation and correction to h4 of the initial medwatch 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, and because the phenomenon was not duplicated during device evaluation, the root cause of the phenomenon could not be identified.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 (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: 17187669
• MDR Text Key: 318191804
• Report Number: 3002808148-2023-06303
• Device Sequence Number: 1
• Product Code: NWB
• UDI-Device Identifier: 04953170301995
• UDI-Public: 04953170301995
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K111425
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 08/22/2023

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-S190
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/30/2023
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/25/2023
• Initial Date FDA Received: 06/22/2023
• Supplement Dates Manufacturer Received: 07/13/2023; 08/21/2023
• Supplement Dates FDA Received: 08/09/2023; 08/22/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/08/2013
• 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