MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. VISERA ELITE XENON LIGHT SOURCE

Model Number CLV-S190

Device Problems Defective Device (2588); Output Problem (3005)

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

Event Date 05/25/2021

Event Type  malfunction  

Manufacturer Narrative

The returned device was evaluated.Inspection found the reported customer issue was confirmed.The front panel control failure was observed and faulty scope socket was found causing the brightness level to not function properly.Diaphragm is slightly bent.In addition, the lamp life was observed to be over three hundred hours and is non olympus.The device was noted with updated switch.Based on evaluation findings the reported failure was due to faulty socket attributed to component failure.Probable cause of the failures found could be attributed to use handling and or maintenance issue.This report will be supplemented accordingly following investigations.

Event Description

It was reported that some of the device buttons are not functioning and occasionally showing out a blue light.The issue found during an unspecified procedure.There was no patient harm or injury reported due to the event.No user injury was 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: the issue occurred towards the very end of the case.The unit was being used during the case but they were able to finish the case.The type of procedure performed is not provided.Patient was fine and no harm reported.After the case was completed, the device was replaced with another device.No other information provided.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's investigation.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, the age of the device and repeated use may have been contributing factors.Additionally, some failures could have been prevented by following the ifu.As stated on the ifu (instruction for use) the user manual states: when replacing the examination lamp, use a clean, lint-free cloth to wipe off residual heat compound from the heat sink.If the heat compound is not wiped off completely, the lamp¿s heat efficiency will be impaired and the examination lamp life will be shortened significantly.Olympus will continue to monitor complaints for this device.

• Brand Name: VISERA ELITE 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: 12076708
• MDR Text Key: 258690261
• Report Number: 8010047-2021-08081
• Device Sequence Number: 1
• Product Code: NWB
• UDI-Device Identifier: 04953170301995
• UDI-Public: 04953170301995
• 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,health
• Type of Report: Initial,Followup,Followup
• Report Date: 08/02/2021

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-S190
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/11/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/03/2021
• Initial Date FDA Received: 06/28/2021
• Supplement Dates Manufacturer Received: 06/26/2021; 08/02/2021
• Supplement Dates FDA Received: 07/13/2021; 08/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1