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

Model Number CV-180

Device Problems No Display/Image (1183); Poor Quality Image (1408)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

The suspect device has not been returned for evaluation and a root cause cannot be identified at this time.If the device is returned, an evaluation will be completed and the results of the evaluation provided in a follow up report.

Event Description

A user facility reported to olympus horizontal, vertical and diagonal lines and vertical color bars on the image after replacing cables due to a "complete black monitor" when using their cv-180, evis exera ii video system center.There was no patient harm or injury reported to olympus.The intended procedure is unknown.It is unknown if the intended procedure was completed.

Manufacturer Narrative

This supplemental report is submitted to provide the results of the legal manufacturer¿s investigation and device history record (dhr) review.The dhr was reviewed for the subject device.No anomalies were noted and it was verified the device was manufactured in accordance with documented specifications and procedures.The legal manufacturer performed an investigation.A conclusive root cause could not be identified.Possible causes, as determined by the legal manufacturer, include failure of the internal board (ap/dr/dp) of the cv-180.It is possible that the inner substrates of the cv-180 were damaged due to degradation associated with the age of the device.

• 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: 10072153
• MDR Text Key: 222564776
• Report Number: 8010047-2020-02789
• 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: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 10/21/2020

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: Health Professional
• Device Model Number: CV-180
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/27/2020
• Initial Date FDA Received: 05/19/2020
• Supplement Dates Manufacturer Received: 09/28/2020
• Supplement Dates FDA Received: 10/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1