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

Model Number CLV-S40PRO

Device Problem Break (1069)

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

Event Type  malfunction  

Manufacturer Narrative

The device has not been returned to any of the olympus locations.The exact cause of the reported event has not yet been identified by legal manufacturer olympus medical systems corp.(omsc) for this device.This report will be supplemented as additional information becomes available.

Event Description

A customer reported that the front panel of the device flashed.There was no report of patient injury associated with this event.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information.The device was returned to olympus service operation repair center (sorc) for inspection.The inspection confirmed that the light guide connector was damaged.Device history record review indicates that the device was manufactured and tested in accordance with all applicable procedures and met all final product release criteria.The front panel of the device is designed to blink when a light guide error occurs.Therefore, olympus medical systems corp.(omsc) assumed that the reported event was caused by the defect of the light guide connector.This defect may have been caused by long-term use.

• 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: 11382911
• MDR Text Key: 234042666
• Report Number: 8010047-2021-03022
• 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: 04/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/25/2021
• 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?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1