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

Model Number OEV262H

Device Problem Failure to Power Up (1476)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/08/2020

Event Type  malfunction  

Manufacturer Narrative

The subject device in this report has not been returned to omsc for evaluation.The exact cause of the reported event could not be conclusively determined at this time.If additional information becomes available, this report will be supplemented.

Event Description

Olympus medical systems corp.(omsc) was informed that during a gastroscopy using the subject device, the subject device was losing power intermittently.The user completed the procedure with the subject device.There was no report of patient injury associated with this event.

Manufacturer Narrative

This supplemental report is being submitted to provide the subject device evaluation result.The subject device was not returned to olympus medical systems corp.(omsc) for evaluation.Omsc confirmed that the subject device had passed 4 years and 5 months since it was manufactured.The exact cause of the reported event could not be conclusively determined.However, there was the possibility that this phenomenon was attributed to the failure of the image processing circuit board or the power supply circuit board.

• Brand Name: HIGH DEFINITION LCD MONITOR
• Type of Device: HIGH DEFINITION LCD MONITOR
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• MDR Report Key: 10216224
• MDR Text Key: 213252749
• Report Number: 8010047-2020-03776
• Device Sequence Number: 1
• Product Code: FET
• Combination Product (y/n): N
• PMA/PMN Number: K102379
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 12/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: OEV262H
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1