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

Model Number CLV-S40PRO

Device Problems Electrical /Electronic Property Problem (1198); Output Problem (3005)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

The device was returned to olympus for evaluation.The user facility report is confirmed and found a faulty power supply.Additionally, the device was found to have rust on the top cover, lamp door, front panel chassis.It was also found that the front panel was damaged and separated from the unit.Olympus service is still in progress.If new information becomes available following service, a supplemental report will be filed.

Event Description

The user facility reported the main lamp does not light.It was reported that the bulb was replaced but the issue persists.There was no patient involvement associated to this report.

Manufacturer Narrative

The investigation has been completed.A device history record (dhr) review was performed and found no non-conformances that would cause the reported malfunction.All records indicate that the device was manufactured in accordance with all applicable procedures.The instructions for use (ifu) states: ¿do not store the light source, lamp(s) or power cord in any of the locations listed below.Damage to the equipment may result: places exposed to high temperatures, high humidity, or liquids.Places exposed to direct sunlight, x-rays, radioactivity or strong electromagnetic.Radiation (e.G., near microwave or short-wave medical treatment equipment, mri or radio equipment).¿ the root cause could not be conclusively determined.Probable causes that could have led to the reported event include the user hitting a hard object and giving a strong impact.Also, nine years or more have passed since the delivery of the device, and it is assumed that the equipment was worn out due to repeated use for a long period of time.

• 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: 10609740
• MDR Text Key: 214151376
• Report Number: 8010047-2020-07026
• 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: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 01/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2020
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/15/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1