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

Model Number CLV-S190

Device Problem Device Alarm System (1012)

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

Event Date 09/20/2022

Event Type  malfunction  

Event Description

The customer reported that his olympus visera elite xenon light source¿s emergency lamp indicator was blinking during use.Additional details relating to the patient and the event have been requested, but no response has been received at this time.There was no patient harm or consequence reported as a result of this event.

Manufacturer Narrative

The device was returned, and an initial evaluation was conducted by olympus; however, investigation is ongoing.During the initial evaluation, the user¿s report was confirmed.The emergency lamp indicator was flashing and an e207 error code was displayed.Additionally, the connection was difficult to make due to wear of the output connector on the light guide side.If additional information becomes available following the device evaluation, a supplemental report will be filed.

Manufacturer Narrative

This report is being submitted to capture additional information received from the initial reporter.That information is located in b3 & b5.Should further information be provided, another supplemental report will be submitted.

Event Description

Additional information was received noting that the subject device was not inspected prior to use.Furthermore, the initial report noted that this event occurred prior to beginning the diagnostic procedure.Reportedly, the procedure was confirmed completed ¿ though specific details were not provided.The customer did state that there was a 2¿3-minute delay was observed, and there was no harm to the patient.Event date confirmed as 20sept2022.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.It has been over 5 years since the subject device was manufactured.Based on the results of the legal manufacturer's investigation, it was determined that the reported phenomena (1) ¿spare lamp is blinking¿ and (2) ¿error code e207 is displayed¿ were duplicated and they occurred due to a faulty spare lamp.According to the service manual, e207 indicates clv spare lamp failure, and it is the message that is displayed when the spare lamp of a light source device is burned out.A review of the device history record found no deviations that could have caused or contributed to the reported issue.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: 15615352
• MDR Text Key: 307090338
• Report Number: 3002808148-2022-03230
• 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,User Facility,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 12/02/2022

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: 09/27/2022
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/27/2022
• Initial Date FDA Received: 10/17/2022
• Supplement Dates Manufacturer Received: 11/07/2022; 11/11/2022
• Supplement Dates FDA Received: 11/08/2022; 12/02/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/02/2017
• 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