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

Model Number CLV-S40PRO

Device Problem Defective Device (2588)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The device has not returned to olympus medical systems corp.(omsc) for evaluation.There were no further details provided.If significant additional information is received, this report will be supplemented.

Event Description

Olympus service operation repair center was informed from the facility that during a procedure with the device, the all led of the front panel of the device are turned on and the examination light of the device became dark.Olympus inspected the device at the service department of olympus and found that the cooling fan of the device was broken and the ac power inlet of the device was burnt.Other detailed information was not provided.There was no report of patient injury associated with the event.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information.Olympus medical systems corp.(omsc) could not investigate the device, because the device was not returned to omsc.Device history record review indicates that the product was manufactured and tested in accordance with all applicable procedures and met all final product release criteria.Olympus service operation repair center (sorc) checked the device and found that the reported phenomenon was duplicated.Since the device was not returned, the exact cause was unknown.Based upon the information from complaint, omsc surmised that the reported phenomenon was occurred the following cause.As 9 years or more has passed since the manufacture date of the device, omsc surmised that the burn of the ac power inlet of the device was occurred due to the device was repeated using on a long-term.As 9 years or more has passed since the manufacture date of the device, omsc surmised that the inside of the device became hot due to the cooling fan was broken due to the device was repeated using on a long-term.And the all led of the front panel of the device are turned on and the examination light of the device became dark occurred.

• 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
• MDR Report Key: 11330926
• MDR Text Key: 233179892
• Report Number: 8010047-2021-02664
• Device Sequence Number: 1
• Product Code: GCT
• Combination Product (y/n): N
• PMA/PMN Number: K062049
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 03/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: CLV-S40PRO
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1