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

Model Number CLV-190

Device Problem Break (1069)

Patient Problem No Patient Involvement (2645)

Event Date 02/02/2021

Event Type  malfunction  

Manufacturer Narrative

Device was evaluated.Inspection of the device found broken power switch and was noted to be an old type switch.The bulb life was found to be over 500 hours and needs to be replaced.Based on evaluation findings the reported failure was confirmed.The failure was found to be due to broken power switch and an old type switch.The investigation is ongoing; therefore, the root cause of the reported failure cannot be determined at this time.However, if additional information becomes available this report will be supplemented accordingly.

Event Description

It was reported that the device power switch malfunctioned, the power button broke.There was no patient involvement on this event reported.No user injury reported.

Manufacturer Narrative

This report is being supplemented to provide additional information based on customer response and updates.Further communication with the customer conveyed the following information: the power switch malfunction occurred on 02feb2021 after a procedure.There was no delay in the procedure in which the device was used.The intended procedure was completed.The same device was used to complete the procedure.No devices were replaced during the procedure.The product will not be returned to olympus.There was no patient injury associated with this event.The device has not been dropped and the power button has not been struck with a hard or pointed object.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's investigation.The following sections were updated: g3, g6, h2, h4, h6 and h10.A review of the device history record found no deviations that could have caused or contributed to the reported issue.All records indicated that the product was manufactured according to all applicable procedures and met final product release criteria.No abnormalities were found.Based on the results of the investigation, from the date of manufacture (2012/04/27), it is assumed that the power switch was damaged due to the amount of operating force applied to the power switch and the number of times that the power switch was exceeded its use.Bulb was over the set life hours, it is speculated that user did not follow the ifu (instructions for use), used a non-desired lamp (non-specified product).As stated on the ifu (instruction for use) the user manual states: 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.Olympus will continue to monitor complaints 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
• MDR Report Key: 11381037
• MDR Text Key: 233749445
• Report Number: 8010047-2021-03012
• Device Sequence Number: 1
• Product Code: NWB
• UDI-Device Identifier: 04953170298868
• UDI-Public: 04953170298868
• 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: company representative,user f
• Type of Report: Initial,Followup,Followup
• Report Date: 04/05/2021

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
• Device Catalogue Number: CLV-190
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/06/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/08/2021
• Initial Date FDA Received: 02/25/2021
• Supplement Dates Manufacturer Received: 03/01/2021; 03/23/2021
• Supplement Dates FDA Received: 03/05/2021; 04/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1