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

Model Number CLV-S40PRO

Device Problem Failure to Power Up (1476)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The device in this report has not been returned to olympus medical systems corp.(omsc) for evaluation.The exact cause of the reported event could not be conclusively determined at this time.If additional information becomes available, this report will be supplemented.

Event Description

The user found the following: the front panel flashed when the light guide was inserted and removed to the video system center.The inlet of the device was burnt and carbonized.There was no report of patient injury associated with this event.The user facility did not provide other detailed information.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information.The subject device was not returned to olympus medical systems corp.(omsc), but was returned to olympus service repair operation center (sorc).Sorc was able to confirm the front panel flashed while the light guide was inserted and removed to the video system center, as reported by the user facility.Additionally, sorc found the inlet burnt.Omsc reviewed the manufacture history (dhr) of the subject device and confirmed no irregularity.The exact cause of the reported phenomenon could not be conclusively determined.However, based upon the information from sorc, the front panel flashed could have been attributed to failures of the mesh turret and the filter turret motor due to aging deterioration due to repeatedly long-term use.The inlet burnt could have occurred due to repeatedly long-term use.

• 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
• MDR Report Key: 11271087
• MDR Text Key: 240123676
• Report Number: 8010047-2021-02165
• Device Sequence Number: 1
• Product Code: GCT
• Combination Product (y/n): N
• PMA/PMN Number: K062049
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 03/19/2021

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: No Information
• Device Model Number: CLV-S40PRO
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/12/2021
• Initial Date FDA Received: 02/03/2021
• Supplement Dates Manufacturer Received: 02/24/2021
• Supplement Dates FDA Received: 03/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1