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

Model Number CLV-190

Device Problems Crack (1135); Defective Device (2588)

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

Event Date 04/21/2021

Event Type  malfunction  

Manufacturer Narrative

The referenced device was returned to the service center for evaluation and confirmed the reported malfunction.The evaluation found the front panel's buttons were non-functional and the external case near the scope connector was damaged/cracked.In addition, the scope socket slider switch was worn out causing intermittent use of high intensity mode.There is corrosion in the air tubing.Also, a non-olympus lamp (with 300+ hours), was within specifications, however, it is strongly recommend the customer use an olympus xenon lamp for better performance.The device was repaired to standard specifications and returned to the customer.A review of the repair history shows no previous repair records; the device was purchased on (b)(6) 2016.The investigation is ongoing; therefore, the root cause of the reported malfunction cannot be determined at this time.However, if additional information becomes available, this report will be supplemented accordingly.

Event Description

The biomed technician at the user facility reported.During inspection before use the evis exera iii xenon light source's control screen on the right hand side was reportedly non-functional and the front case has a big crack.The intended procedure was completed without issue using another light source in another room.There was no patient injury or adverse outcome to the patient.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's investigation.The following sections were updated: g3, g6, h2, h4, h6, and h10.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Based on the results of the legal manufacturer's investigation, it is likely the front panel was damaged by application of force (such as hitting a solid object).In addition, it has been more than 5 years since the subject device was delivered, and it is likely that the lamp deteriorated over time by long-term repeated use.The instruction manual identifies the following verbiage, which may have prevented the panel damage: "do not apply excessive force to this video system and/or other instruments connected.Otherwise, damage and/or malfunction can occur".

• 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: 11863001
• MDR Text Key: 251927904
• Report Number: 8010047-2021-06602
• 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: 06/23/2021

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: 04/29/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/22/2021
• Initial Date FDA Received: 05/21/2021
• Supplement Dates Manufacturer Received: 06/17/2021
• Supplement Dates FDA Received: 06/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1