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

Model Number CLV-S190

Device Problem Break (1069)

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

Event Type  malfunction  

Manufacturer Narrative

The device was evaluated at olympus service operation repair center (sorc).As a result of the evaluation, sorc confirmed that the reported phenomenon was reproduced.More than 7 years have passed since the device was delivered.When the device is used frequently, the cooling fan may have failed due to aging.As a result, it is possible that the device was switched to an emergency lamp because it overheated due to an increase in the internal temperature due to the inability to cool the inside of the device.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.

Event Description

Olympus medical systems corp.(omsc) was informed by the user that the cooling fan broke down and the emergency lamp worked instead of the examination lamp.There was no report of patient injury associated with the event.

• Brand Name: VISERA ELITE 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: 12322629
• MDR Text Key: 266680027
• Report Number: 8010047-2021-10260
• Device Sequence Number: 1
• Product Code: NWB
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: CLASS2-EXMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,user facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 08/16/2021

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-S190
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/26/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/26/2021
• Initial Date FDA Received: 08/16/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2013
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1