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

Model Number CLV-S40

Device Problem Power Problem (3010)

Patient Problem No Information (3190)

Event Date 01/13/2021

Event Type  malfunction  

Manufacturer Narrative

This event is under investigation.A supplemental report will be submitted upon completion of the investigation or upon receiving additional information.

Event Description

It was reported the visera xenon light source spare lamp was illuminated.It was further reported the heat sink assembly was completely missing.No information regarding patient involvement was provided.

Manufacturer Narrative

This supplemental report is being filed to provide the results of the manufacturer's investigation.As part of the investigation, a review of the device history record (dhr) and a review of the instructions for use (ifu) were conducted.The review of the dhr did not find any abnormalities or anomalies identified during production.The device met all specifications upon release.The root cause of "the main lamp could not be turned on" is the heat sink assembly including the main lamp was not installed.It is assumed the emergency light was turned on.It was noted by an olympus representative that there was no heat sink assembly including the main lamp.Service personnel advised the customer to procure replacements if the heat sink assembly (including the main lamp) could not be found.The following statement is included in the ifu: "confirm that the main lamp (xenon) is mounted securely.".Olympus will continue to monitor the performance of this device.

• Brand Name: VISERA 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: 11297248
• MDR Text Key: 233828702
• Report Number: 8010047-2021-02383
• Device Sequence Number: 1
• Product Code: GCT
• Combination Product (y/n): N
• PMA/PMN Number: K954451
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 03/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CLV-S40
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1