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

Model Number CLV-S190

Device Problem Intermittent Loss of Power (4016)

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

Event Date 09/28/2023

Event Type  malfunction  

Event Description

The customer reported to olympus that during an unknown procedure, the light source was turned on, but the ignition of the lamp periodically failed and was switched to the spare lamp.There was no patient harm associated with the event.

Manufacturer Narrative

The device was returned to olympus for evaluation, and the customer's allegation that lamps regularly failed to turn on and switch to emergency lights was confirmed due to a defective igniter board.Three attempts were made at the user facility for additional information on the event with no response.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information from the customer.See updated sections b5, d10, g3, and h10.

Event Description

Additional information has been supplied by the customer.Removal of stones in the kidney endoscopically (rirs) was the intended procedure.It was reported that the procedure was completed successfully with another trolley.Due to the reported issue of the lamp periodically failing and switching to the spare lamp, there was a delay of about five minutes while changing the trolley, but it did not have an effect on the patient's health.The outcome of the procedure was that the patient had the stone removed from the kidney.

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.It has been over 8 years since the subject device was manufactured.Based on the results of the investigation, it was confirmed that the event occurred due to a defective igniter board.However, the specific root cause of the defective igniter board 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: 18069786
• MDR Text Key: 327622834
• Report Number: 3002808148-2023-12274
• Device Sequence Number: 1
• Product Code: NWB
• UDI-Device Identifier: 04953170301995
• UDI-Public: 04953170301995
• Combination Product (y/n): N
• Reporter Country Code: DA
• 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
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 01/28/2024

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: 10/16/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/08/2023
• Initial Date FDA Received: 11/03/2023
• Supplement Dates Manufacturer Received: 11/09/2023; 01/25/2024
• Supplement Dates FDA Received: 11/10/2023; 01/28/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/06/2015
• 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
• Treatment: FLEXIBLE OLYMPUS CYSTOSCOPE, UNKNOWN SN.; OEV191H HIGH DEFINITION LCD MO, SN: (B)(6).; VIDEO SYSTEM CENTER, UNKNOWN SN.