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 Patient Involvement (2645)

Event Date 06/24/2020

Event Type  malfunction  

Manufacturer Narrative

The device was not returned to olympus for evaluation.The cause of the reported event cannot be determined.If additional information becomes available at a later time, this report will be supplemented.

Event Description

It was reported during preparation for use, when the scope is connected to the facility's model cv-180 with an maj-1430 videoscope cable, the scope image doesn't display, only color bars are shown.Troubleshooting with another videoscope cable did not resolve the issue.The model cv-180 is to be repaired.

Manufacturer Narrative

This report is being supplemented to provide the legal manufacturer¿s investigation summary regarding this report.A physical evaluation of the complaint device could not be conducted as the device was not returned to olympus.A review of the dhr confirmed that there was no abnormality in manufacturing, concession, and variation.The root cause of the user's experience could not be conclusively concluded.The complaint device has been in use for 13 years.It is presumed that the event occurred due to long-term use of the product, and that the contact of the video connector receiver is corroded, or that dust, lint, etc.Are adhered to the contact, so that electrical connection with the scope cannot be made.

• 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: 10285816
• MDR Text Key: 223651286
• Report Number: 8010047-2020-04485
• 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,user f
• Type of Report: Initial,Followup
• Report Date: 10/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/16/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CV-180
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1