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

Model Number CLV-190

Device Problems Defective Component (2292); Device Sensing Problem (2917)

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

Event Type  malfunction  

Manufacturer Narrative

The device was returned for investigation.Upon evaluation of the device, scope slide detection mechanism was not functioning properly.The scope must be forced upward before the clv-190 recognizes that it tested.The unit passed all functional inspection after being tested with a test scope socket as well as 180 and 190 model scopes.The scope socket require replacement due to faulty scope detection slide.Furthermore, the front panel and top cover is cracked/bent in the corner.Lastly, the chassis and rear panel is bent in the rear.The investigation is ongoing; therefore, the root cause of the reported event cannot be determined at this time, however, if additional information becomes available, this report will be supplemented accordingly.

Event Description

A user facility reported to olympus that the evis exera iii xenon light source has a dim or low light.During a standard service inspection of the customer returned device, damage was discovered with the lever that activates the high intensity light.This report is to capture the scope detection sensor failure reportable malfunction noted at estimation.There was no patient injury or harm reported.

Manufacturer Narrative

This follow up report is being submitted to include the device history record(dhr) review and results from the legal manufacturer investigation.The legal manufacturer performed the dhr review for this device and all records indicated that the product was manufactured according to all applicable procedures and met final product release criteria.Since the subject device was manufactured more than eight and half years ago, the lever of the high-intensity light in the connector part was damaged by repeated use of the endoscope for a long period of time and the scope detection was not performed correctly.It is presumed that the phenomenon of not switching to the high brightness mode occurred as a result.The instructions for use (ifu) states: "do not apply excessive force to the light source and / or other instruments connected.Otherwise, damage and / or malfunction can occur." 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: 12050953
• MDR Text Key: 257825959
• Report Number: 8010047-2021-07895
• 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: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 07/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/23/2021
• 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: 06/04/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1