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

Model Number CV-180

Device Problem Electromagnetic Interference (1194)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/25/2020

Event Type  malfunction  

Manufacturer Narrative

The subject device referenced in this report has not yet been returned to omsc for evaluation.Therefore, the exact cause of the reported event could not be conclusively determined at this time.A supplemental report will be submitted, if additional or significant information becomes available at a later time.

Event Description

Olympus medical systems corp.(omsc) was informed from the user that during the preparation for use, white balance setting could not work.There was no report of patient injury associated with the event.Olympus (b)(4) checked the subject device and found that the reported phenomenon was duplicated, and more than one function is activated when pressing the button on the front panel.Also, it was written that ¿this is caused by faulty cp board.Video socket is worn out and does not lock scope at all.Top cover is deeply scratched.Card mechanic is mechanically damaged.These parts will be replaced.Front panel is slightly scratched and there is no need for replacement.¿.

Manufacturer Narrative

This is a supplemental report to provide additional information.The subject device was not returned to olympus medical systems corp.(omsc) for evaluation.The manufacturing record was reviewed and found no irregularities.Based on the past similar cases, it was assumed that it is presumed that the user pointed it out because of unintended action when he pressed the front panel.More than 13 years have passed since the device was delivered, and it is assumed that the components on the board deteriorated over time and the cp board failed due to repeated use for a long period of time.The cp board controls the front panel, and it is assumed that this failure caused the front panel to malfunction.

• 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: 11221570
• MDR Text Key: 228956893
• Report Number: 8010047-2021-01815
• Device Sequence Number: 1
• Product Code: FAJ
• Combination Product (y/n): N
• PMA/PMN Number: K133538
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 02/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/25/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: CV-180
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1