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

Model Number CLV-180

Device Problem Use of Device Problem (1670)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/09/2020

Event Type  malfunction  

Manufacturer Narrative

The referenced light source was returned but the investigation is in progress.However, if additional information becomes available, this report will be supplemented accordingly.

Event Description

The service center was informed that during preparation for use of a colonoscopy procedure, the power on button worked, however, the air and other buttons on the light source were unresponsive.The procedure was completed using the same light source.There was no patient injury reported.Additionally, it was unknown if any pointed or hard objects were ever used to press the buttons on the front panel.And there was no damage or abnormality observed.

Manufacturer Narrative

The light source unit was returned to the service center for evaluation of the reported ¿the air button or other buttons on the machine were not working¿.A visual inspection of the device found no abnormalities.The output socket and all the front panel buttons were functional.It was noted the light source equipped with an md-631 xenon lamp with lamp life of 200+ hours.The air function of the light source was checked passed the measurable inspection.When light source setting was on high, the air pressure and air output met the standard specifications.The lightsource was then checked with a test endoscope, and observed that the air flow, brightness output were normal.Additionally, the service group noted there were charred fuse components on the socket switch regulator and stains on the turret lens filter.Based on the evaluation findings, the cause of the reported event could not be confirmed as the air button and all other buttons on the front panel are functioning as designed.The light source was repaired and returned to the user facility.A review of the service history indicated the scope was purchased on (b)(6) 2012 with two service events via repair in the last three years.The last repair was performed on (b)(6) 2019.Per ifu, the air and water feeding function is not available when no endoscope is connected to the light source.The function is available only when a compatible fiberscope or videoscope is connected.When the light source is turned off, the airflow regulator setting is automatically stored and recalled when the light source is turned on again.Also, the air button will turn off, if the light guide is connected to the output socket.Connect the light guide to an endoscope with air feed capability.

Manufacturer Narrative

This supplemental report was submitted to provide additional information to mdr# 8010047-2020-01921.The original equipment manufacturer (oem), omsc, performed a device history record review and no abnormalities were noted.No device was returned to the oem, 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 root cause has been determined to be due to temporary abnormal operation of front panel.

• 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: 9913241
• MDR Text Key: 208338881
• Report Number: 8010047-2020-01921
• 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,Followup
• Report Date: 10/07/2020

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: No Information
• Device Model Number: CLV-180
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/11/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/09/2020
• Initial Date FDA Received: 04/01/2020
• Supplement Dates Manufacturer Received: 04/11/2020; 09/16/2020
• Supplement Dates FDA Received: 04/30/2020; 10/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1