MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. EVIS EXERA II VIDEO SYSTEM CENTER

Model Number CV-180

Device Problems No Display/Image (1183); Defective Device (2588)

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

Event Date 10/12/2021

Event Type  malfunction  

Event Description

The olympus (omsi) field service engineer was informed by the user facility that during preparation for use, when any scope is connected with the evis exera ii video processor there is no image coming onto the lcd (liquid crystal display) monitor.Additionally, the switches on the front panel of video processor are not working and the front panel led (light emitting diode) is on.No patient injury or harm was reported to olympus.

Manufacturer Narrative

The investigation is ongoing; therefore, the root cause of the reported malfunction cannot be determined at this time.However, if additional information becomes available a follow up medical device report will be supplemented accordingly.

Manufacturer Narrative

The referenced processor was returned to the regional repair workshop.The reported issue was confirmed as no there was no image due to a defective receptacle unit.Additionally, an external chemical or liquid was found on the patient board and the upper portion of the fan was missing.Externally, the pc card hold was damaged.There is rusting on the rear panel, discoloring/yellowing on the front panel, rust on the rear panel connectors and scratches on the top cover.The inspection indicated the warranty sticker was removed from processor and some screw was missing.It appears third party repairs were performed but was denied by the customer.The investigation is ongoing; therefore, the root cause of the reported issue/malfunction cannot be determined at this time.However, if additional information becomes available a follow up medical device report will be supplemented accordingly.

Event Description

There was no patient involved.The event was found during preparation for use.There was no delay because procedure had not started.The device was returned to the olympus regional repair center/workshop.

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 10 years since the subject device was manufactured.The investigation results confirmed there was no image due to a defective receptacle unit.The specific root cause of the defective receptacle unit could not be determined at this time.Olympus will continue to monitor field performance for this device.

• Brand Name: EVIS EXERA II VIDEO SYSTEM CENTER
• Type of Device: VIDEO SYSTEM CENTER
• 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: 12694457
• MDR Text Key: 284200815
• Report Number: 8010047-2021-13609
• Device Sequence Number: 1
• Product Code: FAJ
• UDI-Device Identifier: 04953170215513
• UDI-Public: 04953170215513
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K133538
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 01/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/25/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CV-180
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/13/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/16/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/24/2012
• 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