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

Model Number CLV-190

Device Problem Intermittent Energy Output (4025)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/09/2020

Event Type  malfunction  

Manufacturer Narrative

As part of our investigation, the service center provided the customer instruction to change the lamp.Instructed the customer to clean the dust for proper air flow.The lamp will be not returned for evaluation.The customer did not change the lamp but reseated the heat sync and said the unit is working as it should.The cause of the reported event cannot be determine.However, the instruction manual warns users ¿avoid using the light source in a dusty environment.This may damage the light source.¿.

Event Description

The service center was informed that the lamp went into standby during an unspecified procedure.The customer cycled the light power and the lamp came back on.It was reported that the lamp life meter was at 400 hrs.There was dust noted around the light source vents.It is unknown if the procedure was completed.There was no patient injury reported.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information.The legal manufacturer reviewed the contents of this complaint.The legal manufacturer reported that the root cause has not been identified.However, the legal manufacturer reported that the probable cause for the reported event was as follows: (1) the lamp went out during use.Because there was dust around the ventilation grills and when the power of the clv was cycled, the lamp lighted up again, it is presumed that the event occurred because the lamp could not be cooled due to the blockage of the ventilation grills.The following is described in ""8.2 troubleshooting guide"" on the instruction manual of the clv-190.Irregularity description: the examination lamp does not ignite."3.3 installation of equipment" on the instruction manual of the clv-190.Keep the ventilation grills of the light source clear.The ventilation grills are located on the rear panels.Blockage can cause overheating and equipment damage.Clean and vacuum dust the ventilation grills using a vacuum cleaner.Otherwise, the light source may break down and gets damaged from overheating.".

• 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: 9929827
• MDR Text Key: 222001316
• Report Number: 8010047-2020-02010
• Device Sequence Number: 1
• Product Code: NWB
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 11/06/2020

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?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/08/2020
• Initial Date FDA Received: 04/06/2020
• Supplement Dates Manufacturer Received: 10/13/2020
• Supplement Dates FDA Received: 11/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1