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

Model Number CLV-190

Device Problems Break (1069); Insufficient Cooling (1130); Loose or Intermittent Connection (1371)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The device was returned to olympus repair center for evaluation.The evaluation of the device confirmed that the fan did not rotate due to dust.The reported event was caused by the fan rotation failure.If additional information becomes available, this report will be supplemented.

Event Description

Clv temperature error (e101) occurred.There was no report of patient injury associated with this event.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation and to correct information provided on the initial report.In addition to the confirmed fan failure, the olympus repair center found the heat sink of the xenon bulb was loose and proved difficult to lock in place.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, the following causes were identified: 1.The error code e101 (unit temperature error): as supported by the device evaluation, it is likely the device was used in a dusty environment, or the user failed to maintain it according to instructions, causing dust to be collected in the ventilating hole and fans.As the result, the fan failed to cool the inside of the device causing an abnormally high temperature and leading to the e101 error code.For the cautions about dust, the following statements are included in the instructions for use which could prevent the event: "avoid using the light source in a dusty environment.This may damage the light source.Clean and vacuum dust the ventilation grills using a vacuum cleaner.Otherwise, the light source may break down and gets damaged from overheating." 2.The loose heat sink of the xenon lamp: it is likely the user failed to tighten the heat sink clamp firmly during the replacement of the lamp.To prevent this event, the following is included in the instructions for use: "be sure to tighten the heat sink clamp firmly.Poor heat radiation may result in equipment damage, examination lamp ignition failure, and a considerable decrease in the life of the examination lamp.".

• 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: 10732467
• MDR Text Key: 222548771
• Report Number: 8010047-2020-08141
• 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: user facility
• Type of Report: Initial,Followup
• Report Date: 01/15/2021

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: 09/30/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/29/2020
• Initial Date FDA Received: 10/26/2020
• Supplement Dates Manufacturer Received: 12/09/2020
• Supplement Dates FDA Received: 01/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1