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

Model Number CLV-S40PRO

Device Problem Mechanical Problem (1384)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The device was returned, and an investigation was conducted by olympus.During the initial evaluation, the user report could not be confirmed.The device was inspected and tested, and both turret wheels were functioning properly without any issue.Further evaluation noted significant wear and tear on the rest of the device.The bottom chassis, inside top cover, and rear foot were all rusted.Corrosion was noted on the bracket case.Additionally, a non-olympus lamp was being utilized with the device with missing lamp washers.The lamp life meter was reading below 50 hrs, had a worn out scope socket and a worn out slider switch.Charred fuse components were noted on the socket switch regulator, which would indicate a bad switch regulator.Despite the previously mentioned wear and tear, the light intensity output measured within range, the fan was functioning properly, and contained an upgraded igniter and iris cable.The ifu contains the following statement: turn the light source off and disconnect the power cord.Should the equipment become soiled with blood or other potentially infectious materials, first wipe off all gross debris using a neutral detergent, then wipe with a lint-free cloth moistened with a surface disinfectant.Wipe the surface of the light source using a soft, lint-free cloth moistened with 70% ethyl or isopropyl alcohol to remove dust, dirt, etc.Dry the light source with a clean, lint-free cloth.¿ the ifu goes on to note ¿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 fire.¿ the review of the dhr did not find any abnormalities or anomalies identified during production.The device met all specifications upon release.Fourteen components were replaced, successfully tested, and the device was returned to the customer on (b)(6) 2020.The root cause could not be determined.Probable causes include improper maintenance of the device, age of the device and the use of a non-approved olympus lamp.Olympus will continue to monitor the field performance of this device.

Event Description

As reported, during procedure preparation, the visera pro xenon light source's wheel was not turning for the max lighting setting.There was no patient harm or consequence reported as a result of this event.

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 19-jun-2020.Olympus will continue to monitor the field performance of this device.

• Brand Name: VISERA PRO 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: 11207750
• MDR Text Key: 228002437
• Report Number: 8010047-2021-01681
• Device Sequence Number: 1
• Product Code: GCT
• UDI-Device Identifier: 04953170228933
• UDI-Public: 04953170228933
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K062049
• 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: 10/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/21/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CLV-S40PRO
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/07/2020
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/02/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/28/2011
• 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