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

Model Number CLV-180

Device Problem Defective Device (2588)

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

Event Type  malfunction  

Manufacturer Narrative

The device was returned to the service center for evaluation.The reported malfunction was not confirmed as there were no errors found during testing.However, found a damaged front panel with detached front panel ribbon cable; unable to use front panel buttons, a worn out scope socket causing unstable connection.Lamp has over 500 hours, light output below specifications.The device was repaired to standard specifications and returned to the customer.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

The service center was informed, during preparation for use the evis exera ii xenon light source reportedly had an intermittent error issue.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.Although the reported intermittent error was not reproduced during the physical evaluation,, the equipment has been manufactured for more than 14 years and delivered for about 6 years, therefore it is likely that the turret unit and main board have malfunctioned due to aged deterioration.Additionally, the front panel did not work because the ribbon cable was disconnected.The ribbon cable was removed because it was forgotten to be attached when the internal inspection or cleaning was performed.The legal manufacturer will continue to monitor the field performance of this device.

• Brand Name: EVIS EXERA II 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: 11829096
• MDR Text Key: 250862072
• Report Number: 8010047-2021-06325
• Device Sequence Number: 1
• Product Code: NWB
• UDI-Device Identifier: 04953170215544
• UDI-Public: 04953170215544
• 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
• Report Date: 06/29/2021

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-180
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/20/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/21/2021
• Initial Date FDA Received: 05/14/2021
• Supplement Dates Manufacturer Received: 06/24/2021
• Supplement Dates FDA Received: 06/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1