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

Model Number CV-180

Device Problem Noise, Audible (3273)

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

Event Date 03/31/2021

Event Type  malfunction  

Manufacturer Narrative

The customer gave the information that the issue of the beeping has resolved itself.The device is not being returned.As such a definitive root cause of the reported complaint cannot be determined at this time.Supplemental report(s) will be filed as the information becomes available.

Event Description

As reported for this event, during an unknown procedure the device had an audible beeping sound from the white balance button.The white balance of the scope could be done, and there was no problem with the image.The front panel switch appeared to be sticking.There was no problem when the white balancing was done with the keyboard.There was no harm or adverse impact to the patient or procedure.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's 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 legal manufacturer's investigation, follow-up was conducted to blueprint the system, and based on the information received that the problem was solved, it is inferred that there was no abnormality in the device, and that it was a malfunction phenomenon that occurred because the user interrupted the system set-up.Regarding the front panel button "sticking", it is likely the button becomes stuck due to repeated use over a long period of time.It has been more than 12 years since the device was manufactured, and over 8 years since delivery.

• 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
• MDR Report Key: 11724280
• MDR Text Key: 271152366
• Report Number: 8010047-2021-05419
• Device Sequence Number: 1
• Product Code: FAJ
• UDI-Device Identifier: 04953170215513
• UDI-Public: 04953170215513
• Combination Product (y/n): N
• PMA/PMN Number: K133538
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 06/01/2021

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: CV-180
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/31/2021
• Initial Date FDA Received: 04/26/2021
• Supplement Dates Manufacturer Received: 05/17/2021
• Supplement Dates FDA Received: 06/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SCOPE,MAJ-1428 KEYBOARD.