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

Model Number CV-180

Device Problem No Display/Image (1183)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/13/2020

Event Type  malfunction  

Manufacturer Narrative

Since the subject device has not been returned to omsc for the 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 from the user that the image of the subject device had a problem during the preparation for use for the unspecified procedure.At the incoming inspection for the repair, olympus (b)(4) checked the subject device.It was identified that the image of the subject device was a pink colored display due to the print circuit board failure.There was no patient injury associated with this report.

Manufacturer Narrative

Since the subject device was not returned to olympus medical systems corp.(omsc), it could not be investigated.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 report of olympus india, omsc surmised there was the possibility this phenomenon was attributed to the printed circuit board failure of the subject device which have occurred due to the deterioration of the printed circuit board parts which have occurred by the repeated use for the long-term passing more than 9 years since manufacturing the subject device.In the printed circuit board, the image signal is processed, and it is considered that the image might have became the pink color by this failure.If additional information becomes available, this report will be supplemented.

• 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: 10526098
• MDR Text Key: 214652566
• Report Number: 8010047-2020-06457
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 11/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/12/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CV-180
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1