MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. EVIS EXERA III XENON LIGHT SOURCE

Model Number CLV-190

Device Problem Failure to Shut Off (2939)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The suspect device was returned to olympus and evaluated.The reported problem was confirmed.The evaluation determined the power switch was broken and an upgrade to a new version switch was required.

Event Description

Olympus received a report from the user facility that the power button was stuck in the on position.There was no patient injury or harm, associated with the problem, reported to olympus.

Manufacturer Narrative

This supplemental report is submitted to provide the results of the legal manufacturer¿s investigation and device history record (dhr) review.The dhr for the subject device was reviewed and it was verified the device was manufactured in accordance with documented specifications.The legal manufacturer performed an investigation.A conclusive root cause was not identified.The legal manufacturer determined the likely cause was damage to the power switch related to the design.

• Brand Name: EVIS EXERA III 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: 10417505
• MDR Text Key: 223647415
• Report Number: 8010047-2020-05527
• 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: user facility
• Type of Report: Initial,Followup
• Report Date: 01/04/2021

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: Health Professional
• Device Model Number: CLV-190
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/20/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/21/2020
• Initial Date FDA Received: 08/17/2020
• Supplement Dates Manufacturer Received: 12/07/2020
• Supplement Dates FDA Received: 01/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1