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

Model Number CLV-190

Device Problem Communication or Transmission Problem (2896)

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

Event Type  malfunction  

Manufacturer Narrative

The suspect device was returned to olympus and evaluated.The reported problem could not be duplicated; an endoscopic image was produced on the monitor without any error messages.However, it was noted that deposits and corrosion were present on the output socket connector and rust was present on the chassis and front panel display.The investigation is ongoing and the root cause of the reported event cannot be determined at this time.If additional information becomes available, this report will be supplemented accordingly.

Event Description

A user facility reported to olympus that a "b30" error occurred during preparation for use.There was no patient injury, associated with the problem, reported to olympus.

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.It has been over 9 years since the subject device was manufactured.Based on the results of the legal manufacturer's investigation, b30 was displayed as a result of oxidation located on the connector¿s contact pins.Humidity on the scope connector, such as corrosion and deposits, are likely to have caused the malfunction reported by the customer.Though the cause of the corrosion damage on the output socket connector cannot be identified, it can be surmised that improper use likely contributed to the event.Insufficient drying of the endoscopes connector before insertion can cause corrosion over time.The same applies to signs of corrosion noticed on the chassis as well as on the front panel frame.This may have had a detrimental effect on the device¿s performance and caused it to breakdown.The instruction manual identifies the following related verbiage which could help prevent the phenomenon: ¿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." also stated in the instruction manual: ¿if fluids are spilled on or into the light source, stop operation of the light source immediately and contact olympus.¿ 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: 13049205
• MDR Text Key: 285526766
• Report Number: 8010047-2021-16458
• Device Sequence Number: 1
• Product Code: NWB
• UDI-Device Identifier: 04953170298868
• UDI-Public: 04953170298868
• Combination Product (y/n): N
• Reporter Country Code: DA
• 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
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 02/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2021
• 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: 11/25/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/27/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/11/2012
• 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