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 Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/09/2020

Event Type  malfunction  

Manufacturer Narrative

As part of our investigation, the technical assistance center (tac) assisted the customer with troubleshooting.Tac provided the customer instruction on how to obtain the correct video cable sync connections to the monitor and to disconnect the extra connection.The customer was able to get a color bar image.The customer then removed the printer and the remote was correct but had an extra video connection which was removed.The question to the print saved images was updated to ¿no.¿ once the printer was unlocked the customer was able to print color bars and colors looked good.The unit was not returned to the service center for evaluation.In addition, the legal manufacturer (lm) reviewed the content of this complaint for further investigation.The device was delivered to the customer on (b)(6) 2009.The legal manufacturer was unable to determine the root cause.The lm reported that the most probable cause for the reported event is as follows: it was judged that there was no error in the device, and that the problem occurred because the connection between the monitor and processor and the printer and processor were not properly established.As the results of the dhr review, it was confirmed that there was no abnormality in manufacturing, concession, and variation.

Event Description

The service center was informed that no image was observed on the monitor and printer.There was no patient involvement.

Manufacturer Narrative

This supplemental report is being submitted to update the investigation codes.Please see the updates in sections: g4, g7, h2, h6 and h10.

• 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: 11712367
• MDR Text Key: 270919493
• Report Number: 8010047-2021-05248
• Device Sequence Number: 1
• Product Code: FAJ
• UDI-Device Identifier: 04953170215513
• UDI-Public: 04953170215513
• Combination Product (y/n): N
• PMA/PMN Number: K133538
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 05/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/22/2021
• 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: 05/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1