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

Model Number CLV-190

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/17/2020

Event Type  malfunction  

Manufacturer Narrative

The field service technician observed main light element burned out.Replaced main lamp.Equipment repaired and verified according to original equipment manufacturer(oem).Software attributes have been verified and confirmed.The cause could not be determined.No further information was reported.

Event Description

The customer reported to olympus that the device's lamp was out.There was no patient injury reported.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information.Additional information received from the user facility states event occurred during inspection prior to use.The device was not used.No patient involvement.

Manufacturer Narrative

This supplemental report was submitted to provide additional information to mdr# 8010047-2020-05473.The original equipment manufacturer (oem), 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.It is assumed that the device in question had been over 4 years since its manufacture, and it was caused by a failure of the lamp due to long-term use, or an event that occurred because the user did not notice the description in the instruction manual and used it over the time spent using the lamp.A review of the device's repair history shows the device was purchased on july 17, 2013 with no previous repair records.Olympus will continue to monitor the field performance of this device.The instructions for use states, the average lamp life is approximately 500 hours of continuous use (with intermittent use, the lamp life may vary slightly.) confirm that the examination light is emitted from the distal end of the endoscope (see figure 4.5).When the lamp light intensity decreases even if the ¿500 h¿ indicator does not light up, replace the examination lamp with a new one as described in section 6.1, ¿replacement of the examination (xenon) lamp¿.

• 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: 10405239
• MDR Text Key: 202972262
• Report Number: 8010047-2020-05473
• 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,Followup
• Report Date: 11/11/2020

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-190
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/19/2020
• Initial Date FDA Received: 08/13/2020
• Supplement Dates Manufacturer Received: 09/01/2020; 10/14/2020
• Supplement Dates FDA Received: 09/29/2020; 11/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1