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

Model Number CLV-190

Device Problem Electrical /Electronic Property Problem (1198)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

The device was returned to olympus for evaluation.During the evaluation, the reported issue was confirmed due to a non-olympus lamp intermittently failing.The light output was below specifications.A worn-out scope slider switch was found, causing intermittent use of high intensity mode.Corrosion was found in the air tubing.No other issues were found during the device inspection.If additional information is obtained a supplemental report will be filed.

Event Description

A user facility reported that the main lamp was not turning on during preparation for use of a xenon light source.There was no patient involvement or injuries reported.No additional information has been obtained.

Manufacturer Narrative

This supplemental report is being submitted to provide the results of the manufacturer's investigation.As part of the investigation, a review of the device history record (dhr) and a review of the instructions for use (ifu) was conducted.The dhr review did not identify any abnormalities or anomalies identified during production.The device met specifications upon release.The root cause of the reported failure (main lamp not turning on) was determined to be use of a non-olympus lamp for over its lamp usage time.The root cause of the worn scope socket slider switch found during investigation was determined to be wear from use over time.The root cause of the corroded ventilation tube found during investigation was determined to be insufficient drying before connection of the scope.The ifu contains the following statements that may help prevent the reported failure: - "never install a lamp that has not been approved by olympus.The use of a nonapproved lamp can cause damage to the light source and ancillary equipment, malfunction or a fire." - "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." the ifu contains the following statements that may help reduce wear on the scope socket slider switch: - "do not apply excessive force to the light source and/or other instruments connected.Otherwise, damage and/or malfunction can occur." the ifu contains the following statements that may help prevent corrosion of the ventilation tube: - "before connecting the endoscope connector to the light source, confirm that the endoscope connector, including the electrical contacts are completely dry and clean.If the endoscope is used with the electrical contacts wet and/or dirty, the endoscope and light source may malfunction." olympus will continue to monitor for similar complaints.

• 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: 11342339
• MDR Text Key: 232353590
• Report Number: 8010047-2021-02835
• Device Sequence Number: 1
• Product Code: NWB
• UDI-Device Identifier: 04953170298868
• UDI-Public: 04953170298868
• 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: 04/26/2021

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-190
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/27/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/06/2021
• Initial Date FDA Received: 02/18/2021
• Supplement Dates Manufacturer Received: 04/07/2021
• Supplement Dates FDA Received: 04/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1