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

Model Number CLV-190

Device Problem Electrical Shorting (2926)

Patient Problem No Patient Involvement (2645)

Event Date 07/08/2020

Event Type  malfunction  

Manufacturer Narrative

During troubleshooting with the customer, the technical assistance center explained to the customer that they need to replace the lamp and provided the part # for the lamp maj-1817.The customer reported that the main lamp was replaced and all of the front panel leds were still blinking.The device was returned to the service center for evaluation.The reported ¿led lights across the front panel dashboard were blinking" was confirmed.Additionally, the slider switch was found defective.The air duct assembly was cracked and the pump was damaged.A non-olympus lamp- reading over 500+hours.The unit was repaired and returned to the customer.A review of the history indicates the device was purchased on (b)(6) 2015 with no previous repair records.The cause of the reported event could not be determined at this time as the investigation is ongoing.However, if additional information becomes available this report will be supplemented accordingly.

Event Description

The service center was informed by the user facility that the evis exera iii xenon light source was receiving an n207 error and the led lights across the front panel dashboard were blinking.No patient involvement was reported.

Manufacturer Narrative

This supplemental report was submitted to provide additional information from the original equipment manufacturer (oem) for mdr# 8010047-2020-08576.No device was returned.The oem performed a device history record review and no abnormality was found.The oem completed the investigation and determined that there was no manufacturing, material or processing related cause for this failure mode.Based on the investigation results, the oem determined the possible cause of the reported malfunction (defective slider switch) was due to the following: the device has been more than 5 years since the manufacturing.The oem presumed that the deterioration due to long-term use or excessive force application resulted in slider switch malfunction.As stated on the ifu (instruction for use) and as a preventive measure, the user manual states: before connecting the endoscope connector to the light source, confirm that the endoscope connector, including the electrical contacts, is completely dry and foreign objects such as detergent remnants, hard water residue, finger grease, dust, and lint are not on the electrical contacts.If the endoscope is used with wet and/or dirty electrical contacts, the endoscope and light source may malfunction.Never apply excessive force to connectors.This could damage the connectors.Handling of the device is described below in the instruction manual.Olympus will continue to monitor complaints for this device.

• 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: 10791555
• MDR Text Key: 225941824
• Report Number: 8010047-2020-08576
• 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
• Report Date: 01/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/05/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: CLV-190
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/13/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1