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

Model Number CLV-190

Device Problems Corroded (1131); Mechanical Problem (1384); Component or Accessory Incompatibility (2897)

Patient Problems No Consequences Or Impact To Patient (2199); No Information (3190); No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

The device was returned to olympus for evaluation.The evaluation on 29dec2020 confirmed the user's report.The switch was an old version that was damaged and requires upgrade to a new version.Additionally, it was found the scope socket slider switch was worn out, causing intermittent use of high intensity mode.The incorrect lamp was also installed with light output below specs.On the housing, corrosion was found on the chassis and the top cover was scratched.A loaner was provided and the unit was repaired.This event is under investigation.A supplemental will be submitted upon receiving additional information.

Event Description

It was reported the power switch on the evis exera iii xenon light source needs to be replaced.No other information was provided.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer¿s final investigation.As a result of the physical inspection and functional testing of the device, olympus has concluded that the failure of the power switch was most likely caused by repeated use over a long period of time.In addition, the unit was produced prior to a design change made to the switch on 26-nov-2013 based on the legal manufacturer¿s investigation, the device history record (dhr) was reviewed and there were no problems found during the manufacturing of the device that would cause or contribute to the reported issue.The device met all specifications at the time of shipment.

Event Description

Additional information was provided by the customer on 19jan2021.It was reported the event occurred in the middle of the procedure (type of procedure unknown).The procedure was completed with the same device.No other devices were replaced during the procedure.No patient harm or injury was reported.It was further reported the the device was unable to power on or off.No resistance was encountered when powering the device on or off.The device was inspected and no abnormalities were noted.No error codes were displayed.

• 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: 11159094
• MDR Text Key: 243490999
• Report Number: 8010047-2021-01264
• Device Sequence Number: 1
• Product Code: NWB
• UDI-Device Identifier: 04953170298868
• UDI-Public: 04953170298868
• 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,Followup
• Report Date: 03/11/2021

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: 12/24/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/29/2020
• Initial Date FDA Received: 01/13/2021
• Supplement Dates Manufacturer Received: 01/19/2021; 03/03/2021
• Supplement Dates FDA Received: 01/26/2021; 03/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1