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

Model Number CLV-S40PRO

Device Problem Unintended Power Up (1162)

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

Event Type  malfunction  

Manufacturer Narrative

Olympus medical systems corp.(omsc) could not investigate the device, because the device was returned to sorc but not returned to omsc.Therefore, the exact cause of the reported event could not be conclusively determined.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.Based on evaluation performed by sorc, omsc presumed that the reported event occurred due to the following.More than 10 years have passed since the subject device was delivered, and the igniter and converter have deteriorated due to repeated use for a long period of time.The examination lamp failed to light due to the deterioration of the igniter and converter, and the emergency light turned on.Also, the burn of ac power inlet was caused by repeated use for a long period of time.

Event Description

Olympus medical systems corp.(omsc) was informed by the user that during the unspecified timing, the emergency lamp lit up and went out.The device was returned to olympus service operation repair center (sorc).Sorc checked the subject device and found that the reported phenomenon was duplicated.In addition, it was found that emergency lamp lit up due to deterioration of the igniter and the converter and the ac power inlet of the subject device was burnt.Other detailed information was not provided.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: 11663968
• MDR Text Key: 245382394
• Report Number: 8010047-2021-04929
• 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,distri
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/14/2021
• 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?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/23/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/12/2010
• 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