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

Model Number CLV-190

Device Problem Device Sensing Problem (2917)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/29/2021

Event Type  malfunction  

Manufacturer Narrative

The device was returned, and an initial evaluation was conducted by olympus; however, investigation is ongoing.During the initial evaluation, the user report was confirmed, the scope connector port was damaged.As noted, the sensor on the scope detector was damaged, causing no image to appear.Additionally, there was cosmetic damage noted on the front panel, and the lamp life meter was reading at over 500+ hours.If additional information becomes available following the device evaluation, a supplemental report will be filed.

Event Description

The customer originally returned their evis exera iii xenon light source because it was experiencing a scope connector port issue during a diagnostic procedure.According to the initial reporter, the procedure was completed by using a travel cart unit, and there was no negative impact to the patient.During the device evaluation, it was discovered that the scope detection sensor had failed.This report is being submitted to capture the failed scope detection sensor.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.The device met all specifications at the time of shipment.Based on the results of the investigation, the scope connector port was found to be damaged, causing the reported issue.The root cause of the damaged scope connector port could not be determined.Olympus will continue to monitor field performance 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
• Manufacturer Contact: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 13053227
• MDR Text Key: 282614830
• Report Number: 8010047-2021-16518
• Device Sequence Number: 1
• Product Code: NWB
• UDI-Device Identifier: 04953170298622
• UDI-Public: 04953170298622
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: CLASS2-EXMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date: 01/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2021
• 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: 11/29/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/23/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/22/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1