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

Model Number CV-180

Device Problems Circuit Failure (1089); No Display/Image (1183)

Patient Problem No Consequences Or Impact To Patient (2199)

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 facility that the image of the subject device couldn't be displayed on the monitor before the unspecified procedure.The user replaced the system including the subject device to another system and completed the procedure.The service department of olympus (b)(4) (oekg) checked the subject device and identified it was occurred due to the print circuit board failure.There was no report of patient injury associated with this event.The user did not provide the other detailed information.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information.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 the service department of olympus europe se & co.Kg (oekg), omsc surmised there was the possibility this phenomenon was attributed to dx printed circuit board failure which is equipped with the compout connector due to the long-term use of the subject device since manufacturing in february 2007.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: 10231405
• MDR Text Key: 223653826
• Report Number: 8010047-2020-03905
• 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: 09/24/2020

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: No Information
• Device Model Number: CV-180
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/11/2020
• Initial Date FDA Received: 07/06/2020
• Supplement Dates Manufacturer Received: 08/31/2020
• Supplement Dates FDA Received: 09/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1