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

Model Number CLV-S40PRO

Device Problem Display or Visual Feedback Problem (1184)

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

Event Type  malfunction  

Event Description

A user facility returned the olympus, model clv-s40pro, visera pro xenon light source to olympus for repair due to a report that the device did "not start when the power was turned on." upon inspection and testing of the returned device, it was determined the brightness adjustment did not function.This report is submitted due to the brightness adjustment did not function.As this problem was found during in-house service of the device, there was no patient involvement.

Manufacturer Narrative

The device was evaluated by olympus.The evaluation found that the brightness adjustment did not work due to diaphragm failure.The investigation is ongoing and the root cause of the reported event cannot be determined at this time.If additional information becomes available, this report will be supplemented accordingly.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.It has been over 13 years since the subject device was manufactured.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Based on the results of the legal manufacturer's investigation, a root cause could not be identified.It was not possible to determine whether the indicated phenomenon occurred due to the failure of the device.The occurrence of the phenomenon was not confirmed in the repair department.Other inspection findings were as follows: high intensity mode failure due to the deteriorated high intensity motor; turret moves slowly due to the deteriorated turret motor olympus will continue to monitor field performance for 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: 13483916
• MDR Text Key: 296252026
• Report Number: 8010047-2022-02587
• Device Sequence Number: 1
• Product Code: GCT
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K062049
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 04/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2022
• 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: 01/20/2022
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/08/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/28/2008
• 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