MAUDE Adverse Event Report: SHIRAKAWA OLYMPUS CO., LTD. EVIS EXERA III XENON LIGHT SOURCE

Model Number CLV-190

Device Problems Thermal Decomposition of Device (1071); Communication or Transmission Problem (2896)

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

Event Date 09/06/2022

Event Type  malfunction  

Event Description

The customer reported to olympus, there were issues with the lamp of the lightsource and was unsure if the lamp bulb was burnt.There were no reports of patient harm associate with the event.

Manufacturer Narrative

The device was returned, and the reported allegation was confirmed.A device evaluation revealed, the lamp life meter reading was expired over five hundred hours.Additionally, the scope socket loose slider switch was worn out which caused faulty high intensity mode.Also, the front panel label was faded.All the listed parts had to be replaced.All other functionality tested ok.The investigation is ongoing and follow up with the facility is currently being performed.A supplemental will be submitted on completion of investigation or if any additional information is available.

Manufacturer Narrative

Three attempts were performed to obtain additional information, but no response was received from the customer.This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.Please see the updates in sections.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 6 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 due to the lamp life being expired.The following information is stated in the instructions for use (ifu): check the lamp usage indicator.When the ¿500 h¿ indicator on the lamp usage indicator lights up, replace the examination lamp with a new one as described in section 6.1, ¿replacement of the examination (xenon) lamp¿.Olympus will continue to monitor field performance for this device.

• Brand Name: EVIS EXERA III 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: 15550490
• MDR Text Key: 301253824
• Report Number: 3002808148-2022-02827
• Device Sequence Number: 1
• Product Code: NWB
• UDI-Device Identifier: 04953170298868
• UDI-Public: 04953170298868
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: CLASS2-EXMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 11/16/2022

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-190
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/13/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/06/2022
• Initial Date FDA Received: 10/06/2022
• Supplement Dates Manufacturer Received: 10/25/2022
• Supplement Dates FDA Received: 11/16/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/16/2016
• 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