MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. HIGH DEFINITION LCD MONITOR

Model Number OEV191H

Device Problem Display Difficult to Read (1181)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/24/2020

Event Type  malfunction  

Manufacturer Narrative

As part of our investigation, the technical assistance center (tac) offered to assist the customer with troubleshooting.The customer decline as there was no scope connected and there were no direct buttons to presses to zoom the image.Also, the olympus local sale representative was scheduled to be on site.On (b)(6) 2020, tac followed up with the customer and was informed that the sales representative was able to resolve the image issue.The unit was not returned to the service center for evaluation.In addition, the legal manufacturer (lm) reviewed the content of this complaint for further investigation.The legal manufacturer reported that the root cause could not be determined.However, the most probable causes for the reported event are as follows: it was presumed that the event occurred due to a failure of the image processing substrate.The failure of the image processing board was assumed to be normal due to aging since, 12 years and 10 months had passed form date the unit was manufactured.

Event Description

The service center was informed that during an unspecified procedure, the image was zoomed in on the unit but not on the other monitor.The customer reported the image was fine and then suddenly changed.It is unknown if the intended procedure was completed.There was no patient injury reported.

• Brand Name: HIGH DEFINITION LCD MONITOR
• Type of Device: MONITOR
• 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: 11195090
• MDR Text Key: 227585057
• Report Number: 8010047-2021-01606
• Device Sequence Number: 1
• Product Code: HIH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K954451
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 01/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/19/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: OEV191H
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/21/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/25/2007
• 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