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

Model Number CLV-S190

Device Problem Operating System Becomes Nonfunctional (2996)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/11/2020

Event Type  malfunction  

Manufacturer Narrative

Device has not been returned for evaluation.The customer¿s complaint was not confirmed.No findings available.The cause could not be determined.No further information was reported.

Event Description

The customer reported to olympus that the front panel lights of the device were blinking and the buttons were unresponsive.There was no patient injury reported.

Manufacturer Narrative

The investigation has been completed.A device history record (dhr) review was performed and found no non-conformances that would cause the reported malfunction.All records indicate that the device was manufactured in accordance with all applicable procedures.The biomedical engineer at the user facility reported that the issue occurred during the procedure.It was confirmed that no injuries occurred.The device was inspected and the lights were found flashing before a procedure.The instructions for use (ifu) states: ¿insert the light guide connector into the output socket on the front panel of the light source until it clicks.¿ the root cause could not be conclusively determined.Probable causes that could have led to the reported event include the application of excessive force to the socket during the scope connection.

• 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: 10245201
• MDR Text Key: 199062701
• Report Number: 8010047-2020-04010
• 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: 12/30/2020

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-S190
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/11/2020
• Initial Date FDA Received: 07/08/2020
• Supplement Dates Manufacturer Received: 12/04/2020
• Supplement Dates FDA Received: 12/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1