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

Model Number CLV-190

Device Problem Failure to Clean Adequately (4048)

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

Event Type  malfunction  

Manufacturer Narrative

The device was returned and evaluated, and the customer¿s allegation was confirmed due to heavy dust on the unit.Additionally, due to the heavy dust accumulation, the front panel led (light emitting diode) was blinking, the fan was making noise and corrosion was found on the flat cable.The investigation is ongoing, and a supplemental report will be submitted upon completion of the investigation or if any additional information is provided by the user facility.

Event Description

The customer reported to olympus that there was an error code e300 while using the evis exera iii xenon light source.The issue was found during general maintenance and there was no patient harm associated with the event.The device was returned and evaluated, and the front panel led (light emitting diode) was blinking due to heavy dust in the unit.This mdr is being submitted to capture the reportable malfunction found during the device evaluation.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.Based on the results of the investigation, it was determined that the reported phenomenon, ¿front panel led is blinking¿, occurred due to accumulation of dust inside the unit.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.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 (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: 16654802
• MDR Text Key: 313211200
• Report Number: 3002808148-2023-03185
• Device Sequence Number: 1
• Product Code: NWB
• UDI-Device Identifier: 04953170298868
• UDI-Public: 04953170298868
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K131780
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 05/11/2023

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: 03/02/2023
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/02/2023
• Initial Date FDA Received: 03/31/2023
• Supplement Dates Manufacturer Received: 04/14/2023
• Supplement Dates FDA Received: 05/11/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/23/2015
• 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