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

Model Number CLV-S40PRO

Event Date 02/03/2021

Event Type  malfunction  

Manufacturer Narrative

The device was returned to omsc for evaluation.Omsc inspected the device and confirmed the following: the high intensity scope detection sensor of the output socket failed due to deformation of metal parts and wear of the light guide insertion part due to repeated connections.The mesh turret stuck and malfunction occurred.There was no abnormality in the appearance of the lamp.When the light intensity of the device was measured using the olympus actinometer osb-2, it was confirmed that the light intensity was within the standard value.The lid of the device was opened and the inside was checked, and it was confirmed that there was no abnormality.It was confirmed that there was no abnormality after continuous operation for a long time.The exact cause of the reported event could not be conclusively determined.However, the reported event that he ac power inlet was scorched may have been caused by aging due to long-term repeated use, because more than 12 years have passed since the device was manufactured.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) inspected the device and found that the ac power inlet of the device was scorched.There was no report of patient injury associated with the event.

• 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: 11869114
• MDR Text Key: 252154848
• Report Number: 8010047-2021-06648
• 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: company representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 05/24/2021

1 Device 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/15/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/26/2021
• Initial Date FDA Received: 05/24/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2008
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown