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

Model Number CLV-S190

Device Problem Insufficient Cooling (1130)

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 cooling fan of the subject device was broken.A supplemental report will be submitted, if additional or significant information becomes available at a later time.

Event Description

Olympus medical systems corp.(omsc) was informed that during the preparation for use, the cooling fan of the lamp side of the subject device did not work.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.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information.Olympus medical systems corp.(omsc) could not investigate the subject device, because the subject device was not returned to omsc.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.Since the subject device was not returned to omsc, the exact cause was unknown.Approximately 8 years have passed since the subject device was manufactured.Omsc surmised that the reported phenomenon occurred since the cooling fan of the subject device was broken due to aging degradation, if it was used frequently.

• 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
• MDR Report Key: 12370004
• MDR Text Key: 268215806
• Report Number: 8010047-2021-10775
• Device Sequence Number: 1
• Product Code: NWB
• Combination Product (y/n): N
• PMA/PMN Number: CLASS2-EXMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 09/21/2021

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?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/05/2021
• Initial Date FDA Received: 08/26/2021
• Supplement Dates Manufacturer Received: 09/06/2021
• Supplement Dates FDA Received: 09/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1