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

Model Number CLV-190

Device Problems Use of Device Problem (1670); Electrical Shorting (2926)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The device was returned to the service center.The evaluation confirmed the reported "lights on the front start to flash and gives error cvv3" due to a defective scope socket; not detecting the scope.In addition, there was corrosion in the air tubing and the top cover has exposed metal.A non-olympus installed lamp was over 500 hours; light output was below specifications.The device was repaired to standard specifications and returned to the customer.The device was purchased on august 12, 2014 with no previous repair records.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.This mdr is being submitted retrospectively as part of a remediation effort related to recent system and process changes.An investigation has been opened to manage the actions related to remediation of this issue and any required mdr reporting.

Event Description

During preparation for use, the evis exera iii xenon light source's "lights on the front start to flash and gives error cvv3" when a scope is plugged in.No patient injury or harm was reported.

Manufacturer Narrative

This supplemental report was submitted to provide additional information from the legal manufacturer.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.The likely cause of the front panel led flashing and errors is due failure from long term use olympus will continue to monitor complaints for this device.

Manufacturer Narrative

This supplemental report was submitted to provide additional information from the legal manufacturer and to update the following sections: e2, e3, g3, g4, g7, h2, h6 and h10.The biomedical engineer technician at the user facility further reported there were no delays and the intended procedure was completed with the same device.The device was inspected before use and no abnormalities were noted.All settings/connections were inspected and were correct and secured.The investigation is ongoing; however, if additional information becomes available, this report will be supplemented accordingly.

• 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: 11265090
• MDR Text Key: 243854771
• Report Number: 8010047-2021-02125
• 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,user f
• Type of Report: Initial,Followup,Followup
• Report Date: 03/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: CLV-190
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/07/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1