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

Model Number CLV-190

Device Problems Ventilation Problem in Device Environment (3027); Noise, Audible (3273)

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

Event Date 02/28/2022

Event Type  malfunction  

Manufacturer Narrative

The customer was advised to check if there is anything blocking the fan or the vent on the clv-190.Him to the service center representative then informed the customer to isolate the lamp and housing by switching out the assembly with another followed by verifying how long the lamp turns on before this error come up.The customer was advised to also check and confirm that the maj-1933 and maj-1941 cables are secure.Later the informed olympus they have sent the light source in for repair.The suspect device was returned to olympus for evaluation, upon inspection error 101 being displayed was not confirmed.However, the damaged fan was confirmed due to heavy dust.It was also noted a worn-out slider switch socket caused intermittent use of high intensity mode, there was dust inside scope socket, the igniter is firing weak with corrosion inside air pump tubing.It was also noted that a non-olympus lamp life meter is reading below fifty plus (50+) hours, light output measured within range.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

The customer reported to olympus the during an unspecified procedure a rattling noise coming from the fan of their evis exera iii xenon light source with e103 and e101 displaying on the screen.The light source was currently in use and troubleshooting was not possible.There were no reports of patient death, harm, or injuries related to this event.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.It has been over 7 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 legal manufacturer's investigation, the cooling function of the fan deteriorated and the function was confirmed by the repair department.It was estimated that an e101 error has occurred.It was also estimated that the main lamp could not be turned on and that the fan could not rotate properly due to the large amount of dust inside.The instruction manual identifies the following related verbiage which could have prevented the phenomenon: ¿clean and vacuum dust the ventilation grills using a vacuum cleaner.Otherwise, the light source may break down and gets damaged from overheating.¿ 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: 13910469
• MDR Text Key: 297595385
• Report Number: 8010047-2022-05003
• 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: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 05/16/2022

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: 03/09/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/28/2022
• Initial Date FDA Received: 03/25/2022
• Supplement Dates Manufacturer Received: 04/18/2022
• Supplement Dates FDA Received: 05/16/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/07/2014
• 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