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

Model Number CLV-190

Device Problems Corroded (1131); Moisture Damage (1405)

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

Event Type  malfunction  

Event Description

The customer returned the device to olympus for diagnostic check.Upon inspection and testing of the customer returned device, the unit had suffered severe moisture damage and various components are affected and show corrosion.This report is being submitted for the malfunction found during evaluation.There was no harm or user injury reported due to the event.

Manufacturer Narrative

According to the evaluation, the returned device had a defective appearance of: the chassis, harness, front panel, and the board.The investigation is ongoing, and a definitive root cause of the reported event cannot be determined at this time.If additional information becomes available, this report will be supplemented accordingly.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.It has been over 8 years since the subject device was manufactured.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, the device has suffered very severe moisture damage and various components are affected and show corrosion.It was presumed that it was caused by the handling of users.Other inspection findings were as follows: poor appearance of the chassis (rust or dust); poor appearance of harness (rust or dust); poor appearance of front panel (rust or dust); poor appearance of pcb (rust or dust) the instruction manual identifies the following related verbiage which could have prevented the phenomenon: ¿if fluids are spilled on or into the light source, stop operation of the light source immediately and contact olympus.Do not prepare, inspect, or use the light source with wet hands.Store the light source properly in a clean, dustless place in compliance with the environmental conditions given in." (guidance and manufacturer's declaration ¿electromagnetic immunity" on page 118).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: 13585452
• MDR Text Key: 296400590
• Report Number: 8010047-2022-03415
• Device Sequence Number: 1
• Product Code: NWB
• UDI-Device Identifier: 04953170298868
• UDI-Public: 04953170298868
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: CLASS2-EXMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/26/2022

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: 01/27/2022
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/26/2022
• Initial Date FDA Received: 02/23/2022
• Supplement Dates Manufacturer Received: 03/28/2022
• Supplement Dates FDA Received: 04/26/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/25/2013
• 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