MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. EVIS UNIVERSAL LIGHT SOURCE

Model Number CLV-U20D

Device Problem Electrical /Electronic Property Problem (1198)

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

Event Date 08/25/2021

Event Type  malfunction  

Event Description

Olympus medical systems corp.(omsc) was informed from the user that after the procedure using the subject device and trolley, the subject device made a plosive sound and smelled burnt.The trolley was on and the subject device was off.The power cord of the subject device was connected to the trolley.Other detailed information was not provided.There was no report of patient injury associated with the event.

Manufacturer Narrative

The subject device was returned to olympus medical systems corp.(omsc) for evaluation.Omsc confirmed the subject device found that the power plug of the subject device is partially peeled off and when the subject device was turned on, the breaker tripped due to an electric leakage.There was a burning smell from the subject device and the cable near the power inlet of the subject device was burnt.Omsc could not review the device history record of the subject device because more than 15 years have passed since the subject device was manufactured.The exact cause of this event could not be conclusively determined.Omsc surmised that the reported phenomenon occurred since the cable near the power inlet was short-circuited.

Manufacturer Narrative

This mdr is being submitted as part of a retrospective review and remediation effort based on enhancements made to the company¿s mdr and complaint handling processes.Capas have been opened to manage the actions that are being taken to remediate this issue and ensure any required mdr reporting is completed.The aware date should be 25-aug-2021.Olympus will continue to monitor the field performance of this device.

• Brand Name: EVIS UNIVERSAL LIGHT SOURCE
• Type of Device: 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: 12974465
• MDR Text Key: 285760245
• Report Number: 8010047-2021-15877
• Device Sequence Number: 1
• Product Code: GCT
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 10/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/10/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: CLV-U20D
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/06/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/02/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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