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

Model Number OEV191H

Device Problem No Display/Image (1183)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/02/2020

Event Type  malfunction  

Manufacturer Narrative

As part of our investigation, the technical assistance center (tac) assisted the customer with troubleshooting.The customer reported that the image issue only occurs in one room with a particular rf generator.The facility has two different rooms with the same 180 system.The generator works fine in the other room.The customer reported the system was connected to other outlets, swapped the video processor and the video scope cable.It was noted that the phenomenon only occurred when the probe was inside the scope.Tac recommended that the customer swap carts in attempt to isolate the issue and determine if the olympus equipment was the issue.In a follow up call on (b)(6) 2020, the customer reported that the root cause was a bad sync cable on the video cable going to the monitor.The issue is now resolved with the new cable.The device was not returned to the service center for evaluation.A review of the instrument history showed no service/repair record for this unit.This investigation is ongoing and if additional information is received this report will be supplemented accordingly.

Event Description

The service center was informed that during an unspecified procedure, the monitor¿s image was lost.It is unknown if the intended procedure was completed.There was no patient injury report.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.Based on the results of the investigation, the probable cause is likely due to noise on the video signal of the monitor due to high-frequency noise generated by the use of an electric scalpel manufactured by another company.This issue is addressed in the instructions for use (ifu): "dangers, warnings and cautions: before using high frequency electrosurgical equipment, make sure that any signal noise emitted from the equipment does not affect the observation of the surgical procedures.If high frequency electrosurgical equipment is used without such confirmation, patient injury may result.".

Manufacturer Narrative

This mdr is being submitted as part of a retrospective review and remediation effort based on enhancements made to the company¿s mdr and complaint handling processes.Capas have been opened to manage the actions that are being taken to remediate this issue and ensure any required mdr reporting is completed.Correction to g3 of the initial medwatch.The aware date should be 02-jun-2020.Olympus will continue to monitor the field performance of this device.

• 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: 11208137
• MDR Text Key: 228002656
• Report Number: 8010047-2021-01682
• 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,Followup,Followup
• Report Date: 10/03/2022

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: OEV191H
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/22/2020
• Initial Date FDA Received: 01/21/2021
• Supplement Dates Manufacturer Received: 01/25/2021; 10/02/2022
• Supplement Dates FDA Received: 02/16/2021; 10/03/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/21/2007
• 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