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

Model Number CLV-190

Device Problem Operating System Becomes Nonfunctional (2996)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

The light source was returned to the service center for evaluation.A review of the service history indicated the scope was purchased on january 17, 2015 with no prior repair/records.The evaluation confirmed the reported "membrane is stuck, when you turn on you can't select anything on the panel." as the front panel was broken and detached on the right side and the power switch becomes intermittently stuck.Additionally, the rear panel/top cover were dented and the turret motor was damaged.The scope socket tab was loose and is not protecting pins.There was corrosion on the air tubing.The lamp 300+ hours, light output was out of specifications.The damaged housing is likely attributed to excessive force/impact to the housing.

Event Description

The service center was informed that during preparation for use, the biomedical engineer at the user facility reported the "membrane" was stuck; when the xenon light source unit was turned on, the user could not select anything on the panel.The xenon light source unit was replaced with a back-up light source unit.There was no patient involvement.In addition, the biomedical engineer attempted to troubleshoot the light source unit with technical assistance but with no results.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Based on the results of the investigation, it is unlikely that the device would be damaged under normal use, and it is highly likely that a large load outside of the recommended usage conditions would have been instantaneously added from outside.There are direction in the instruction for use to help prevent the front panel switch sticking: "do not use a pointed or hard object to press the buttons on the front panel.This may damage the buttons.Do not place any equipment other than the video system center on the top of the light source.Equipment damage can result.Place the light source on a stable, level surface using the foot holders (maj-1205).Otherwise, the light source may topple down or drop, and operator or patient injury may occur, or equipment damage can result.Do not wipe the external surface with a hard or abrasive wiping material.The surface will be scratched.".

• 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: 10017160
• MDR Text Key: 222564158
• Report Number: 8010047-2020-02437
• 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,user f
• Type of Report: Initial,Followup
• Report Date: 01/11/2021

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: 04/11/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/05/2020
• Initial Date FDA Received: 05/01/2020
• Supplement Dates Manufacturer Received: 01/04/2021
• Supplement Dates FDA Received: 01/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1