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

Model Number CLV-190

Device Problem Use of Device Problem (1670)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/11/2020

Event Type  malfunction  

Manufacturer Narrative

Technical assistance center (tac) noted that no trouble shooting was required as the user was in the process of changing the lamp.The light source was not returned to the service center; therefore the exact cause of the reported event cannot be determined.A review of the light source's history indicates the light source was purchased on december 17, 2017 and has had no previous repairs.The investigation is ongoing, if additional information becomes available this report will be supplemented accordingly.

Event Description

The technical assistance center was informed by the user facility that during an unspecified procedure, the evis exera ii xenon light source lamp had failed; the main lamp was flickering.However, the spare lamp turned on and the user was able to complete the procedure.There was no patient injury reported.

Manufacturer Narrative

This supplemental report was submitted to provide additional information to mdr# 8010047-2020-04121.A review of the asset camera head's history was reviewed which indicated the device was purchased on december 17, 2017 with no previous repair records.As part of the investigation, olympus followed up with the customer to obtain additional information but no further information was obtained.The original equipment manufacturer (oem), omsc, performed a device history record review and no abnormalities were noted.No device was returned to the oem; therefore, the root cause of the reported event could not be determined.However, an investigation was completed by the oem and determined that there is no manufacturing, material or processing related cause for this failure mode.The potential failure of the lamp has been determined to be due to either the life of the xenon lamp from long-term use or the accidental failure of the lamp.

• 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: 10257064
• MDR Text Key: 223652902
• Report Number: 8010047-2020-04121
• Device Sequence Number: 1
• Product Code: NWB
• 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: 10/13/2020

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?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/11/2020
• Initial Date FDA Received: 07/10/2020
• Supplement Dates Manufacturer Received: 09/16/2020
• Supplement Dates FDA Received: 10/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1