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

Model Number CLV-S190

Device Problem Gas/Air Leak (2946)

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

Event Type  malfunction  

Manufacturer Narrative

The subject device was returned to olympus service operation repair center (sorc).Sorc checked the subject device and found that the reported phenomenon was duplicated and the examination lamp of the subject device was not lit up due to a gas leak of the examination lamp.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 upon the information from sorc, olympus medical systems corp.(omsc) surmised that the reported phenomenon occurred due to failure of the examination lamp (a gas leak of the examination lamp).The exact cause of a gas leak of the examination lamp could not be conclusively determined.

Event Description

Olympus medical systems corp.(omsc) was informed that during the unspecified timing, the emergency lamp of the subject device was always on.The event date was unknown.Other detailed information was not provided.There was no report of patient injury associated with the event.This device is an olympus asset.

• Brand Name: VISERA ELITE 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: 13085755
• MDR Text Key: 286109410
• Report Number: 8010047-2021-16849
• Device Sequence Number: 1
• Product Code: NWB
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: CLASS2-EXMPT
• 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: 12/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: CLV-S190
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/03/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/03/2021
• Initial Date FDA Received: 12/26/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/10/2012
• 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