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

Model Number CLV-S190

Device Problem Optical Problem (3001)

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

Event Date 06/08/2021

Event Type  malfunction  

Manufacturer Narrative

The device was returned to an olympus service center for evaluation and the issue was not confirmed.The unit functioned properly according to the technical guide.The image was displayed with no noise or distortion.The unit was tested with cysto-nephro fiberscope (cyf) and ureteroscope (urf) model scopes and the unit passed functional inspection.There was minor cosmetic wear and tear, and the lamp life was more than three hundred (300) hours.The unit had an updated switch.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.

Event Description

The user facility reported to olympus that during preparation for use for a therapeutic procedure, the lamp on the visera elite xenon light source was not lighting.The front panel buttons illumination had shut off when a scope was plugged in, so it was impossible to turn on the lamp bulb.The light indicated that the lamp was on standby when the scope was unplugged, but as soon as the scope was plugged back in, the buttons become inactive.No patient harm reported.

Manufacturer Narrative

This supplemental report is being submitted to provide the results of the legal manufacturer¿s investigation.The device history records for this device were reviewed and all records indicated that the product was manufactured according to all applicable procedures and met final product release criteria.No abnormalities were found.The root cause could not be conclusively specified.Aging deterioration or temporal malfunction of parts of the main board were likely, as nine (9) years had passed since the subject device was delivered.An additional issue was noted with the heatsink assembly having excessive thermal paste.It was likely the issue was caused by applying more than an appropriate amount of heat compound when replacing the lamp.

• 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: 12122588
• MDR Text Key: 280568195
• Report Number: 8010047-2021-08480
• 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: user facility
• Type of Report: Initial,Followup
• Report Date: 08/11/2021

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: 06/08/2021
• Initial Date FDA Received: 07/06/2021
• Supplement Dates Manufacturer Received: 08/11/2021
• Supplement Dates FDA Received: 08/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SCOPE, MODEL # UNKNOWN