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

Model Number CLV-190

Device Problem Fracture (1260)

Patient Problem No Patient Involvement (2645)

Event Date 01/06/2021

Event Type  malfunction  

Manufacturer Narrative

The device was returned, and an initial evaluation was conducted by olympus; however, investigation is ongoing.During the device review, the user report was confirmed.The old version switch was damaged and needed replaced with the updated model.Additionally, the scope socket slider switch was worn out and causing intermittent high intensity mode, and the front panel was damaged.However, the lamp did read at 200 hours with a light output that was within specification.If additional information becomes available following device evaluation, a supplemental report will be filed.

Event Description

As reported, the power switch of the evis exera iii xenon light source was found damaged during reprocessing.There was no patient involvement during this event.

Event Description

Additional information was received from the initial reporter by email.It was noted that the power button was damaged first thing in the morning when the technicians tested the equipment prior to bringing patients in for procedures.The unit was pulled from service as soon as it was noticed it was not working.The subject device was replaced with another device and returned to olympus for repair.There were no other issues or damage noted.There was no residue found in or around the button (power switch).The unit is turned on and off by the technicians on all procedures as they are instructed to by the olympus representative on proper usage.

Manufacturer Narrative

This report is being supplemented to provide additional information received from the initial reporter and the results of the legal manufacturer's final investigation.The following sections were updated: b3, b5, d8, e2, e3, g3, g6, h2, h4, h6 and h10.The device history record (dhr) was reviewed and there were no problems found during the manufacturing of the device that would have caused or contributed to the reported issue.The device met all specifications at the time of shipment.Based on the results of the investigation, the malfunction of the power switch likely occurred because the operating force amount and frequency during application of the power switch exceeded what was expected.A design change to improve the durability of the power switch has since been made.The subject device within this report was manufactured prior to the design change.

• 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: 11275783
• MDR Text Key: 240123840
• Report Number: 8010047-2021-02202
• Device Sequence Number: 1
• Product Code: NWB
• UDI-Device Identifier: 04953170298622
• UDI-Public: 04953170298622
• 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: 03/23/2021

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: 01/12/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/14/2021
• Initial Date FDA Received: 02/03/2021
• Supplement Dates Manufacturer Received: 03/16/2021
• Supplement Dates FDA Received: 03/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1