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

Model Number CLV-S40PRO

Device Problem Electrical /Electronic Property Problem (1198)

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

Event Type  malfunction  

Manufacturer Narrative

The subject device was returned to olympus service operation repair center (sorc).Sorc checked the subject device and found that the reported phenomenon (blinking the front panel) was duplicated due to the failure of mesh turret and filter turret.The exact cause of the reported event could not be conclusively determined at this time.If additional information is received, this report will be supplemented.

Event Description

Olympus medical systems corp.(omsc) was informed from the user that during the preparation for use, when the user activated nbi observation mode with the scope switch, nbi observation mode could not function and the front panel of the subject device blinked occasionally.The power of the subject device was cycled, the issue was resolved sometimes.The occurrence date of the event is unknown.There was no report of patient injury associated with the event.

Event Description

Olympus medical systems corp.(omsc) was informed from the user that during the preparation for use, when the user activated nbi observation mode with the scope switch, nbi observation mode could not function and the front panel of the subject device blinked occasionally.The power of the subject device was cycled, the issue was resolved sometimes.The occurrence date of the event is unknown.There was no report of patient injury associated with the event.

Manufacturer Narrative

The subject device was returned to olympus service operation repair center (sorc).Sorc checked the subject device and found that the reported phenomenon (blinking the front panel) was duplicated due to the failure of mesh turret and filter turret.The exact cause of the reported event could not be conclusively determined at this time.If additional information is received, this report will be supplemented.

Manufacturer Narrative

Corrected data: g2 (foreign, other- japan).This supplemental report is submitted to provide the results of the legal manufacturer¿s investigation, device history record (dhr) review, applicable corrections and additional information.During the device evaluation, the light guide connector was also found to be worn.The review of the dhr did not find any abnormalities or anomalies identified during production.The device met all specifications upon release.Based on the results of the investigation, it is likely the failure was caused by a failure of the filter and mesh turrets.It is unknown, however, what caused the turrets to fail.Olympus will continue to monitor the field performance of this device.

Event Description

The customer reported to olympus, when switching to narrow band imaging (nbi) (in the scoop sw), the front panel of the light source had been blinking without switching prior to an unknown procedure.If power of the subject device is cycled, the issue could resolve sometimes.There were no reports of patient harm associated with this event.

• 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: 13058792
• MDR Text Key: 285456428
• Report Number: 8010047-2021-16619
• Device Sequence Number: 1
• Product Code: GCT
• UDI-Device Identifier: 04953170228933
• UDI-Public: 04953170228933
• 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
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 06/06/2022

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: Health Professional
• Device Model Number: CLV-S40PRO
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/25/2021
• Initial Date FDA Received: 12/22/2021
• Supplement Dates Manufacturer Received: 06/03/2022
• Supplement Dates FDA Received: 06/06/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/21/2009
• 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