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

Model Number CLV-190

Device Problem Material Deformation (2976)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

The device was returned to olympus for evaluation.The user facility report of scope port is damaged was confirmed, the device was found to have front panel damage.The user facility report related to scope not being recognized was not confirmed.The device was tested and video image was found to function normally however; the scope socket slider was found worn and was sticking intermittently and corrosion found in the air tubing.The device was serviced and returned to the user facility.Olympus will continue to monitor complaints for this device.

Event Description

The user facility reported that the scope port is damaged and cannot be connected on the clv-190.There was no patient involvement reported.

Manufacturer Narrative

This supplemental report is being submitted to report the additional information.Please the updates in sections: g4, g7, h2, h4, h6 and h10.The legal manufacturer reviewed the content of this complaint for further investigation.The legal manufacturer reported that the root cause could not be determined.As a result of confirming dhr, it was confirmed that there were no abnormalities in manufacturing, special adoption, and variations.The legal manufacturer reported that the most probably cause for the reported event is the following: scope port is broken and does not recognize when the scope is connected front panel damaged.We speculate that the front panel was broken by the user hitting a hard object and imposing a strong impact.From the photo attached to etq, it is speculated that the plastic part of the output connector is broken so that the inside of the device is visible, that the scope cannot be held stably, and it is considered that it is not recognized even if the scope is connected.Intermittently stack due to slider switch wear in the scope socket the device has been delivered for more than 5 years, and it is assumed that the slider switch has become worn due to repeated use for a long period of time.Use of lamps not specified by olympus.It is speculated that the user did not notice (or ignore) the description in the commentary and attached the desired lamp (non-specified product).Corrosion of the air tube it is speculated that the device has been in place for more than 5 years since its delivery and has occurred due to aging deterioration due to prolonged use.

• 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: 10596479
• MDR Text Key: 221846352
• Report Number: 8010047-2020-06932
• 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: 12/31/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/28/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: CLV-190
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/05/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1