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

Model Number CLV-190

Device Problems Component or Accessory Incompatibility (2897); Device Markings/Labelling Problem (2911)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

As part of the investigation, a device evaluation, review of the device history record (dhr), and review of the instructions for use (ifu) were conducted.The device evaluation could not confirm the user report.The failure could not be duplicated after testing with all scopes.However, the evaluation found the power switch needed to be upgraded and a non-olympus lamp was being used.The caution sign on the front was also damaged but still readable.The review of the dhr did not find any abnormalities or anomalies identified during production.The ifu contains the following statement: "never install a lamp that has not been approved by olympus.The use of a non-approved lamp can cause damage to the light source and ancillary equipment, malfunction or a fire." the root cause could not be established.Possible causes of no image include connection issues and environmental issues.

Event Description

It was reported that during preparation for use, no image was appearing when the scope was connected to the evis exera iii xenon light source.No patient involvement or impact to patient care was reported.

Manufacturer Narrative

This mdr is being submitted as part of a retrospective review and remediation effort based on enhancements made to the company¿s mdr and complaint handling processes.Capas have been opened to manage the actions that are being taken to remediate this issue and ensure any required mdr reporting is completed.Correction to g3 of the initial medwatch.The aware date should be 20-jul-2020.Olympus will continue to monitor the field performance of this device.

• 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
• Manufacturer Contact: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 11247367
• MDR Text Key: 229682647
• Report Number: 8010047-2021-01975
• Device Sequence Number: 1
• Product Code: NWB
• UDI-Device Identifier: 04953170301995
• UDI-Public: 04953170301995
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: CLASS2-EXMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/11/2022

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/29/2020
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/29/2020
• Initial Date FDA Received: 01/28/2021
• Supplement Dates Manufacturer Received: 10/02/2022
• Supplement Dates FDA Received: 10/11/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/21/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1