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

Model Number CV-180

Device Problem Erratic or Intermittent Display (1182)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/01/2021

Event Type  malfunction  

Manufacturer Narrative

The device was returned for investigation.Upon inspection of the cv-180 processor, the reported issue of losing signal was not confirmed.A three-hour burn-in test was performed and the unit functioned normally.Furthermore, all video output signal and images test was satisfactory and the unit has an updated narrow band imaging.The investigation is ongoing; therefore, the root cause of the reported event cannot be determined at this time, however, if additional information becomes available, this report will be supplemented accordingly.

Event Description

It was reported the evis exera iii video system center is intermittingly losing signal to the monitor when using the rgb maj-1584 cable.The device must be turned on/off to retrieve signal.There was no patient involvement, no harm or user injury reported due to the event.

Manufacturer Narrative

This follow up report is being submitted to include the device history record(dhr) review and results from the legal manufacturer investigation.The following sections were updated: d8, h4, h6 and h10.The legal manufacturer performed the dhr review for this device and all records indicated that the product was manufactured according to all applicable procedures and met final product release criteria.Since the subject device was manufactured more than fourteen years ago and was used repeatedly for a long period of time, a presumed temporarily malfunction occurred due to aging deterioration of the image board or a defect occurred due to incorrect setting and connection.The instructions for use (ifu) states: all cables must be connected correctly and completely.If you use the device with an incomplete connection, not only will the device not function correctly, but there is a risk of it being damaged.Olympus will continue to monitor complaints for 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: 12032660
• MDR Text Key: 277423371
• Report Number: 8010047-2021-07774
• 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: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 07/01/2021

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/28/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/27/2021
• Initial Date FDA Received: 06/21/2021
• Supplement Dates Manufacturer Received: 06/29/2021
• Supplement Dates FDA Received: 07/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: RGB MAJ-1584