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

Model Number CLV-190

Device Problems Corroded (1131); Mechanical Problem (1384); Output below Specifications (3004)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

As part of the manufacturer's investigation, an evaluation of the device, review of the device history record (dhr), and review of the instructions for use (ifu) were conducted.The device was returned to olympus for evaluation and repair.The evaluation confirmed the user report.The lamp was improperly installed.In addition, the lamp had 200 hours, the light output was below specifications, there was a worn out scope socket slider switch causing intermittent use of high intensity mode, air output was below specifications, and there was corrosion in the air tubing.The unit was repaired and equipped with a new type switch.The dhr review did not show any abnormalities or anomalies identified during production.The device met all specifications upon release.The root cause for the gap due to improper lamp installation was traced to not sufficiently applying heat compound when the lamp was replaced.The wear on the scope socket slider switch, intermittent high intensity mode, lamp brightness below specifications, corroded air tube, and air leakage are likely due to use over a long period of time.The ifu contains the following statement: apply enough heat compound.If not enough heat compound is applied, the heat can cause lamp ignition failures." olympus will continue to monitor the field performance of this device.

Event Description

It was reported that the customer was having difficulty replacing the bulb of an evis exera iii xenon light source.As reported by the customer, the component that is fitting into the light source is not holding right in the machine.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.The aware date should be 03-dec-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: 11606033
• MDR Text Key: 244363282
• Report Number: 8010047-2021-04475
• Device Sequence Number: 1
• Product Code: NWB
• UDI-Device Identifier: 04953170298868
• UDI-Public: 04953170298868
• 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: 10/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/01/2021
• 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: 12/10/2020
• 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: 05/22/2015
• 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