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

Model Number CLV-S190

Device Problems Communication or Transmission Problem (2896); No Visual Prompts/Feedback (4021)

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

Event Date 04/07/2024

Event Type  malfunction  

Manufacturer Narrative

At this time olympus has not received this device back for testing and evaluation.Should the device be returned, an evaluation will be completed, and a follow up report will be submitted.

Event Description

The customer reported to olympus the visera elite xenon light source lamp went out and was converted to an emergency light and displayed scope communication error (e102).The reported issue occurred during an unknown diagnostic procedure.The procedure was subsequently completed with the same device.There were no reports of patient harm associated with this event.

Manufacturer Narrative

During a follow - up with the user facility, it was confirmed that: the reported issue occurred during preparation of use for a ¿endoscopy in the ear, pharynx, and nasal region in otorhinolaryngology¿ procedure.It was unknown if there were any delays.The investigation is ongoing.A final report will be submitted upon completion of the investigation.

Manufacturer Narrative

This supplemental report is being submitted to provide the results of 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 9 years since the subject device was manufactured.The device was returned to olympus for inspection, and the customer's error e102 (lamp error) was confirmed.A simulation was carried out in order to confirm the allegation.Based on the results of the investigation, it is likely the following led to the malfunction: it is surmised that both events (light went out on the clv-s190 and error e102) were caused due to a problem with the main board.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: 19130269
• MDR Text Key: 341462381
• Report Number: 3002808148-2024-03596
• 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: 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 05/17/2024

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
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/08/2024
• Initial Date FDA Received: 04/18/2024
• Supplement Dates Manufacturer Received: 05/01/2024; 05/14/2024
• Supplement Dates FDA Received: 05/13/2024; 05/17/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/04/2014
• 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: TC-A1 (TROLLEY), OTV-S190 (PROCESSOR)