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

Model Number CLV-S190

Device Problem No Device Output (1435)

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

Event Date 12/11/2023

Event Type  malfunction  

Event Description

The customer reported to olympus, the light source main lamp was not lighting, however the spare was.The issue was found during preparation for a therapeutic laproscopic cholecystectomy procedure.The procedure was completed with another olympus product.There were no reports of patient harm.

Manufacturer Narrative

The device was returned to olympus for evaluation and the evaluation found the main lamp was not glowing and it was shifting to the spare lamp due to a defective convertor.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or if any additional information is provided by the user facility.

Manufacturer Narrative

This supplemental report is being submitted to provide the results of the legal manufacturer's final investigation.New information added to the following field: h6.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over four (4) 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 that the main lamp does not glow and shifts into the spare lamp due to a failure of the converter.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: 18422841
• MDR Text Key: 331672167
• Report Number: 3002808148-2023-14919
• Device Sequence Number: 1
• Product Code: NWB
• UDI-Device Identifier: 04953170301995
• UDI-Public: 04953170301995
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K111425
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 01/30/2024

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-S190
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/18/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/11/2023
• Initial Date FDA Received: 12/30/2023
• Supplement Dates Manufacturer Received: 01/23/2024
• Supplement Dates FDA Received: 01/30/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/10/2019
• 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