MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. EVIS EXERA III XENON LIGHT SOURCE

Model Number CLV-190

Device Problem Defective Device (2588)

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

Event Date 04/09/2021

Event Type  malfunction  

Manufacturer Narrative

During troubleshoot via telephone, the clinical engineer technician reported that the filters were dirty and was causing the unit to overheat.The technician was able to correct the issue by cleaning the filters.And are no longer experiencing an e102 error.The investigation is ongoing; therefore, the root cause of the reported malfunction cannot be determined at this time.However, if additional information becomes available, this report will be supplemented accordingly.

Event Description

During a procedure, the evis exera iii xenon light source was overheating and getting an e102 lamp outage failure error message and the light source kept going into spare lamp mode.There was no delay and the procedure was completed using the same device.There was no patient injury or harm was reported.

Manufacturer Narrative

The legal manufacturer performed the device history records for this device and all records indicated that the product was manufactured according to all applicable procedures and met final product release criteria.No abnormalities were found.The investigation was completed by the legal manufacturer and determined that there is no manufacturing, material or processing related cause for this failure mode.However, since the reported e102 error did not occur after the filter and dust inside the device were cleaned, the legal manufacturer determined that the e102 error occurred due to dust accumulated inside the subject device.This increased the temperature inside the device, so the safety unit was activated.Then, e102 was displayed without turning on the main lamp, and the lamp was switched to the emergency lamp.As stated on the ifu (instruction for use) and as a preventive measure, the user manual states: the legal manufacturer will continue to monitor complaints for this device.

• Brand Name: EVIS EXERA III XENON LIGHT SOURCE
• Type of Device: XENON LIGHT SOURCE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• MDR Report Key: 11766740
• MDR Text Key: 275259548
• Report Number: 8010047-2021-05771
• Device Sequence Number: 1
• Product Code: NWB
• UDI-Device Identifier: 04953170298868
• UDI-Public: 04953170298868
• Combination Product (y/n): N
• PMA/PMN Number: CLASS2-EXMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 06/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/03/2021
• 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?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/31/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1