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 was sent to the olympus service operation repair center (sorc) for inspection.The device is currently being inspected.The exact cause of the reported event has not yet been identified by legal manufacturer olympus medical systems corp.(omsc) for this device.If significant additional information is received, this report will be supplemented.

Event Description

A customer reported that all the lights on the front panel 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 inspection by olympus service operation repair center (sorc) confirmed followings; -the reported event was reproduced.Due to high-brightness motor failure, all the lamps on the front flashed.-due to the failure of the turret motor, the movement of the turret was dull.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.When this device detects a turret error, it is designed to notify by blinking the led on the front panel.Therefore, olympus medical systems corp.(omsc) assumed that the reported event was caused by the turret unit failure.This failure may have been caused by aged deterioration due to long-term use.If significant additional information is received, 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
• MDR Report Key: 11490242
• MDR Text Key: 240741821
• Report Number: 8010047-2021-03738
• 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: 04/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2021
• 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?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/31/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1