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

Model Number CLV-S40PRO

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The device was returned to olympus repair center for evaluation.The evaluation of the device confirmed the followings; defect of the diaphragm to adjust the brightness was noted.The reported event was caused by the defect.A malfunction was noted in which the led of the power switch flashed.If additional information becomes available, this report will be supplemented.

Event Description

Brightness adjustment did not work.The event was found during inspection by olympus repair center.There was no report of patient injury associated with this event.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information.Further evaluation of the device confirmed the followings; defects of filter turret and mesh turret were noted.These defects caused the event that led of the power switch flashed.The device was manufactured over 11 years ago.Device history record review indicates that the product was manufactured and tested in accordance with all applicable procedures and met all final product release criteria.Omsc could not determine the root cause conclusively.Based upon the investigation result, omsc assumed the following as the cause.As the subject device was manufactured over 11 years ago, some mechanical parts such as a diaphragm unit, a filter turret, or mesh turret were age-deteriorated.Therefore, the subject device detected those as defects, resulting in the led blinking.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
• MDR Report Key: 10738370
• MDR Text Key: 224676220
• Report Number: 8010047-2020-08165
• 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: distributor,user facility
• Type of Report: Initial,Followup
• Report Date: 12/11/2020

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: No Information
• Device Model Number: CLV-S40PRO
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/25/2020
• Initial Date FDA Received: 10/26/2020
• Supplement Dates Manufacturer Received: 11/20/2020
• Supplement Dates FDA Received: 12/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1