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

Model Number CLV-S190

Device Problems Failure to Reset (1532); Use of Device Problem (1670); Operating System Becomes Nonfunctional (2996)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The referenced light source was returned to the service center however the evaluation has not yet begun.If additional information becomes available this report will be supplemented accordingly.

Event Description

The service center was informed that during a procedure the light source front panel buttons were unresponsive.The user proceeded to press the reset button and observed a flashing light.The bulb was replaced, pressed the reset button but the light source would not reset.There was no patient injury reported.

Manufacturer Narrative

This supplemental report was submitted to provide additional information from the biomedical engineer at the user facility.There was no delay in the procedure and there was no patient injury.The procedure was completed with the same unit.When the reset button was pressed, it was pressed for more than 3 seconds.The lamp usage indicator did not show "0." it displayed 500 hours.When the they tried to reset the device after replacing the bulb, it went on standby.The light source was inspected and no visible abnormalities were detected.The power plug of the power cord was plugged directly into a grounded wall main outlet.The connections were inspected and found to be secured.There was no cable damage noted.Patient information and other details about the procedure were unknown.

Manufacturer Narrative

This supplemental report was submitted to provide additional information to mdr# 8010047-2020-01923.The reported flashing light was confirmed to be due to bad spare lamp not functioning.The lamp had a reading of over 500 hours.The unit was tested and was functioning normally with an olympus test spare lamp.Front panel buttons were functional.The camera head was repaired and returned to the customer.A review of the device's history was reviewed which indicated the device was purchased on april 26, 2017 and with no previous repair records.The original equipment manufacturer (oem), omsc, performed a device history record review and no abnormalities were noted.No device was returned to the oem, however, an investigation was completed by the oem and determined that there is no manufacturing, material or processing related cause for this failure mode.The potential root cause has been determined to be due to the user did not notice the description in the commentary and did not continue to press the resetting button for more than 3 seconds.Resetting the lamp time display is described below in the instruction manual.1.Connect the power cord and press the power switch: the light source is turned on.2.Press the lamp button on the control panel for 1 second: the examination lamp is turned off, and the ""stby"" indicator lights up.3.Press and hold the counter reset button on the control panel for more than 3 seconds: the lamp usage indicator is reset.Confirm that the lamp usage indicator shows ""0"".

• 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: 9913350
• MDR Text Key: 208332914
• Report Number: 8010047-2020-01923
• 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: company representative,user f
• Type of Report: Initial,Followup,Followup
• Report Date: 09/29/2020

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 Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/19/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/11/2020
• Initial Date FDA Received: 04/01/2020
• Supplement Dates Manufacturer Received: 04/20/2020; 09/03/2020
• Supplement Dates FDA Received: 04/22/2020; 09/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1