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

Model Number CV-V1

Device Problems Electrical /Electronic Property Problem (1198); Poor Quality Image (1408)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/13/2020

Event Type  malfunction  

Manufacturer Narrative

The subject device in this report was not 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 the preparation for an unspecified procedure with the subject device at the user facility, the endoscopic image of the subject device flickered.The service department of olympus (b)(4) checked the subject device and found that endoscopic image flickered and the greenish image appeared, and the main electrical circuit board had failure.There was no dent and/or damage on the exterior.There was no report of patient injury associated with this event.The user facility did not provide other detailed information.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information.The subject device was not returned to olympus medical systems corp.(omsc).However, the main circuit board of the subject device was returned to omsc for evaluation.In the evaluation of omsc, the reported phenomenon was duplicated when the electrical circuit board of the subject device had been incorporated into omsc asset's device.Omsc reviewed the manufacturing history (dhr) of the subject device and confirmed no irregularity.The exact cause of the reported event could not be conclusively determined.However, based on the result of omsc evaluation and the past similar cases, omsc surmised that the reported phenomenon might be occurred due to the inappropriate clock adjustment on the main circuit board during manufacturing.Omsc has already revised the work instruction, but the reported event occurred before the revise.If additional information becomes available, this report will be supplemented.

• Brand Name: 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: 10425156
• MDR Text Key: 203486190
• Report Number: 8010047-2020-05616
• Device Sequence Number: 1
• Product Code: FDF
• Combination Product (y/n): N
• PMA/PMN Number: K111756
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 01/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/19/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CV-V1
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1