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

Model Number CLV-190

Device Problem Accessory Incompatible (1004)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/09/2020

Event Type  malfunction  

Manufacturer Narrative

Upon troubleshooting, the biomed stated he replaced the main lamp in the device and the replacement bulb failed to activate.He purchased the lamp from olympus but could not confirm the part number for the bulb.Tac reminded customer that the device used the maj-1817 xenon lamp.The issue was addressed by replacing the lamp with the correct model.The most likely cause can be attributed to user error.No further information was reported.

Event Description

The customer reported to olympus that during preparation for use, the device was having a brightness issue.The lamp had been used and was at the maximum hours.The lamp that was being switched to was the incorrect lamp part.The device was restarted.There were no error messages, alerts or alarms received.There was no patient injury reported.

Manufacturer Narrative

The device is not returned as the issue was resolved with troubleshooting.Device evaluation is done by communication and historical records.Also, correction is being made to included information reported by user and not included in the initial mdr: the device was inspected and there was no damage or abnormalities.This supplemental report is being submitted to provide this information.The device history record review confirmed that device there were no abnormalities, special adoption, or variations in manufacturing.The user reported that upon replacing the main lamp in the device and the replacement bulb failed to activate.Upon troubleshooting, it was confirmed that the user was had used as replacement an incorrect lamp model not compatible with the device.The incorrect lamp was removed and substituted with the lamp meant for use with the device.The issue of the lamp failing to activate was resolved.Instruction for use description includes: never install a lamp that has not been approved by olympus.The use of a non approved lamp can cause damage to the light source and ancillary equipment, malfunction or a fire.If combinations of equipment other than those shown below are used, the full responsibility is assumed by the medical treatment facility.

• 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: 10220676
• MDR Text Key: 199847603
• Report Number: 8010047-2020-03814
• 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: 10/07/2020

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 the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/08/2020
• Initial Date FDA Received: 07/01/2020
• Supplement Dates Manufacturer Received: 09/16/2020
• Supplement Dates FDA Received: 10/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1