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

Model Number CLV-S40PRO

Device Problems Electrical /Electronic Property Problem (1198); Failure to Power Up (1476)

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

Event Type  malfunction  

Manufacturer Narrative

The subject device has not been returned to omsc but was returned to olympus service operation repair center (sorc) for evaluation.Sorc checked the subject device and duplicated the reported phenomenon.It was found the power supply unit failure of the subject device which caused the reported phenomenon.It was also found that the ac power inlet of the subject device was burnt.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 the subject device turned off automatically and could not turn on again during the unspecified procedure.The intended procedure was completed with another device.The occurrence date of the event is unknown.There was no report of patient injury associated with the event.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information.The root cause of the reported phenomena could not be identified.However based on the inspection report of olympus service operation repair center (sorc), olympus medical systems corp.(omsc) summarized as follows; 1, the subject device turned off automatically and could not turn on again during the procedure.From the following facts obtained in the investigation, it was presumed that the reported phenomenon was caused by the failure of the power supply unit, but the cause of the failure of the power supply unit could not be identified.-sorc confirmed that the power did not turn on and obtained information that it was due to a failure of the power supply unit.-when checking the manufacturing history, it was confirmed that there were no manufacturing abnormalities or corrections.2, the ac power inlet of the subject device was burnt.From the following facts obtained in the investigation, it was not possible to identify the cause of the burnt inlet.-it was found that the inlet was burnt at sorc inspection.-when checking the manufacturing history, it was confirmed that there were no manufacturing abnormalities or corrections.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
• Manufacturer Contact: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 12763893
• MDR Text Key: 283492535
• Report Number: 8010047-2021-14195
• Device Sequence Number: 1
• Product Code: GCT
• 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: User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 12/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2021
• 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: 10/11/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/18/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/29/2007
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1