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 04/20/2021

Event Type  malfunction  

Manufacturer Narrative

Customer called in and spoke with olympus technical assistance center (tac) personnel informing them of the issue he was experiencing.Tac trouble-shot the issue with the customer and discovered that a cable configuration problem was causing the image to not appear.Once this was corrected, and the cables were properly connected, the image was displaying on the monitor.The device is not scheduled for return.If additional information becomes prior to the conclusion of the investigation, a supplemental report will be filed.

Event Description

It was reported, during procedure preparation, the evis exera ii video system center was not displaying an image on monitor.There was no patient harm or consequence reported as a result of this event.

Manufacturer Narrative

This supplemental report is being submitted to provide the results of the manufacturer¿s investigation.A review of the device history record (dhr) was conducted during this investigation.The review of the dhr did not find any abnormalities or anomalies identified during production.The device met all specifications upon release.Per the investigation results, when the cable connection between the cv-180 and the pc was made to using the correct connector, the reported event did not occur.Consequently, it is believed that unintentional user error caused the reported event to happen.Olympus will continue to monitor the field performance of this 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: 11797744
• MDR Text Key: 249775619
• Report Number: 8010047-2021-06096
• 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: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 06/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/10/2021
• 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: 06/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1