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

Model Number CLV-S40PRO

Device Problem Failure to Power Up (1476)

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

Event Type  malfunction  

Event Description

Olympus medical systems corp.(omsc) was informed by the user that the device did not turn on.There was no report of patient injury associated with the event.

Manufacturer Narrative

The device was evaluated at olympus service operation repair center (sorc).As a result of the evaluation, the following was confirmed.The device did not turn on due to a blown fuse due to a converter failure.The high intensity mode did not work due to fatigue of the sensor part of the output socket.The exact cause of the reported event could not be conclusively determined at this time.If additional information becomes available, this report will be supplemented.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information.The exact cause of the reported event could not be conclusively determined.However, based on the following investigation results, olympus medical systems corp.(omsc) surmised that the device did not turn on when the power switch was pressed due to a converter failure.The cause of the converter failure could not be determined.From the evaluation results, it was confirmed that the fuse was blown due to the converter failure and the fuse box was burnt.According to the repair history, the device was replaced the main board, f-panel, and aperture blades in 2009.As a result of reviewing the device history records, there were no manufacturing abnormalities, special hires, or variations.Device history record (dhr) review indicates that the product was manufactured and tested in accordance with all applicable procedures and met all final product release criteria.If additional information becomes available, this report will be supplemented.

• 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: 12764280
• MDR Text Key: 283302607
• Report Number: 8010047-2021-14219
• 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: User Facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 12/06/2021

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: Other
• Device Model Number: CLV-S40PRO
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/12/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/12/2021
• Initial Date FDA Received: 11/07/2021
• Supplement Dates Manufacturer Received: 11/10/2021
• Supplement Dates FDA Received: 12/06/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/16/2006
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1