MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. VISERA ELITE XENON LIGHT SOURCE

Model Number CLV-S190

Device Problems Mechanical Problem (1384); Component or Accessory Incompatibility (2897); Connection Problem (2900); Material Deformation (2976)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

The device was returned to olympus and repaired.Evaluation confirmed the user report of "e300 error and all the lights on the face are blinking" due to a worn out scope socket and slider switch.The worn scope socket and slider switch was also causing the high intensity mode not to work.An expired, non-olympus lamp with over 500 hours was also discovered.The rear panel of the device was found to be deformed and the rear foot was bent.This event is under investigation.A supplemental report will be submitted upon receiving additional information.This mdr is being submitted retrospectively as part of a remediation effort related to recent system and process changes.Actions are being taken to manage the actions related to remediation of this issue and any required mdr reporting.

Event Description

It was reported the visera elite xenon light source displayed the e300 error and all of the lights on the face were blinking.No patient impact or involvement was reported.

Manufacturer Narrative

This supplemental report is being submitted to provide the results of the manufacturer¿s investigation.A review of the device history record (dhr) was conducted during this investigation.The review of the dhr did not find any abnormalities or anomalies identified during production.The device met all specifications upon release.The root cause of the indicators on the front panel blinking, and high intensity mode not working is likely due to wear from prolonged use.Over 6 years have passed since the delivery of this product.It is presumed the output socket and slide switch wore out and failed due to long-term repeated use.It is presumed that the failure of the output socket caused failure in stable connection to the endoscope connector, resulting in occurrence of e300 error (scope err) and blinking of led indicators on the front panel.In addition, it is presumed that the failure of the slide switch affected endoscope connection detection, resulting in failure in switching to the high intensity mode.Olympus will continue to monitor the field performance of this device.

• Brand Name: VISERA ELITE 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: 11163998
• MDR Text Key: 231797225
• Report Number: 8010047-2021-01326
• Device Sequence Number: 1
• Product Code: NWB
• UDI-Device Identifier: 04953170301995
• UDI-Public: 04953170301995
• 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: 02/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/13/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CLV-S190
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/21/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1