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

Model Number CLV-190

Device Problems Air/Gas in Device (4062); Key or Button Unresponsive/not Working (4063)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/29/2022

Event Type  malfunction  

Manufacturer Narrative

Customer called the olympus technical assistance center (tac) support to troubleshoot the device.Customer reported the lamp button will not go from ¿stand by to on.The lamp was replaced twice, but the front panel was locked.The olympus representative instructed customer the customer to power off and ensure both light source cables are secure.Then to open the side panel where the lamp goes and close again to ensure properly seated.The customer was able to turn the clv-190 lamp on when using auto selection on the back of the unit and the lamp lit, but the standby button on the front did not work.The button does not work, and the customer tried reconnecting the maj-1941.The customer wanted to know if a clv-180 could be used and informed the customer it could if using the maj-1959 cable.The device was returned to olympus for evaluation and the customer¿s allegation was not confirmed.The evaluation uncovered the top cover to be deformed, the front panel was damaged on the right side, there was corrosion on the lamp door and a bent on the front panel chassis.Additionally, a non-olympus lamp was used, and it was reading below 50 hours.The light output measured within range.It was recommended customer to have new lamp replacement to a olympus xenon lamp for optimal performance.The power switch was up to date, the fan was running, and the air pressure tested ok.The investigation is ongoing, and a definitive root cause of the reported event cannot be determined at this time.If additional information becomes available, this report will be supplemented accordingly.

Event Description

A user facility reported to olympus that during preparation for a colonoscopy, the evis exera iii xenon light source lamp button will not switch from stand by to on.Additionally, the subject device air is ¿on¿ and cannot cycle through the different levels of low-medium-high and the brightness could not be adjusted on the subject device.The patient was sedated, and the procedure was completed with another device.There was a minimum of 20 minutes delay reported.There was no harm or user injury reported due to the event.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.It has been over 4 years since the subject device was manufactured.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 likely that the reported problems occurred due to a temporary lighting failure of the lamp, or the use of competitor lamp.A front panel malfunction, and malfunctions of the parts related to the brightness adjustment function may have also contributed to the issues.The investigation did not establish definitive root causes.This issue is addressed in the instructions for use (ifu): ¿chapter 6 lamp replacement/ 6.1 replacement of the examination (xenon) lamp always use the examination lamp designated below.To order a new examination lamp, contact olympus.¿ xenon lamp maj-1817.Install an examination lamp as described in section 6.1, ¿replacement of the examination (xenon) lamp¿.¿ olympus will continue to monitor field performance for this device.

• 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
• Manufacturer Contact: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 14230837
• MDR Text Key: 299302078
• Report Number: 8010047-2022-07164
• Device Sequence Number: 1
• Product Code: NWB
• UDI-Device Identifier: 04953170298868
• UDI-Public: 04953170298868
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: CLASS2-EXMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 06/15/2022

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: 04/07/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/29/2022
• Initial Date FDA Received: 04/28/2022
• Supplement Dates Manufacturer Received: 05/18/2022
• Supplement Dates FDA Received: 06/15/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/18/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1