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  

Manufacturer Narrative

The device evaluation revealed the base plate, housing cover, lamp door, front panel, scope socket, and capacitor had corrosion.Additionally, a non-olympus lamp was installed.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

The customer reported to olympus the device had circuit board damage.Upon inspection and testing of the customer returned device, it was observed that the device had moisture penetrating various housing and parts and showed signs of 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

The device evaluation revealed the base plate, housing cover, lamp door, front panel, scope socket, and capacitor had corrosion.Additionally, a non-olympus lamp was installed.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

The customer reported to olympus the device had circuit board damage.Upon inspection and testing of the customer returned device, it was observed that the device had moisture penetrating various housing and parts and showed signs of 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

This report is being supplemented to provide additional information based on the approved final investigation.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 investigation, the definitive root cause of the flooding could not be determined.The instruction manual identifies the following verbiage, which may have prevented the phenomenon: ¿[7.1 care] do not clean the output socket, other connectors, or the ac power inlet.Cleaning them can deform or corrode the contacts resulting in damage to the light source.Do not immerse, autoclave, or gas sterilize the light source.These methods will damage it.[6.1 replacement of the examination (xenon) lamp] never install a lamp that has not been approved by olympus.The use of a nonapproved lamp can cause damage to the light source and ancillary equipment, malfunction or a fire.¿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: 13602036
• MDR Text Key: 286144755
• Report Number: 8010047-2022-03585
• 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: 06/08/2022

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: 02/14/2022
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/31/2022
• Initial Date FDA Received: 02/25/2022
• Supplement Dates Manufacturer Received: 05/13/2022
• Supplement Dates FDA Received: 06/08/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/28/2015
• 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