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

Model Number CLV-S40PRO

Device Problems Electrical /Electronic Property Problem (1198); Overheating of Device (1437)

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

Event Date 04/07/2022

Event Type  malfunction  

Event Description

The customer reported the spare lamp on the light source was also lit when the main lamp was on during preparation for an abdominal exploration procedure.The procedure was completed with another similar device.The subject device was sent to an olympus service center for evaluation.During inspection and testing, the main lamp did not light due to overheating.This report is being submitted for the malfunction found during evaluation (lamp not lighting with overheating).There was no harm or user injury reported due to the event.

Manufacturer Narrative

During inspection and testing, service found the cooling fan did not rotate which caused the unit to overheat.Due to the overheating, the main lamp did not light while the spare lamp lighted automatically.The investigation is ongoing; therefore, the root cause of the reported event cannot be determined at this time.However, if additional information becomes available this report will be supplemented accordingly.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.It has been over 7 years since the subject device was manufactured.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Based on the results of the legal manufacturer's investigation, the ¿main lamp was not lit¿ was not confirmed while the spare lamp was automatically lit at the repair department.Information was obtained from the repair department that the phenomenon was caused by the cooling fan not rotating.Olympus will continue to monitor field performance for this device.

• 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: 14309496
• MDR Text Key: 290943685
• Report Number: 8010047-2022-07743
• Device Sequence Number: 1
• Product Code: GCT
• UDI-Device Identifier: 04953170228940
• UDI-Public: 04953170228940
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K062049
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/06/2022
• 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
• Date Returned to Manufacturer: 04/11/2022
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/07/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/26/2014
• 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
• Treatment: OTV-S7PRO: OLYMPUS VIDEO SYSTEM CENTER