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 Problems No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

There is no additional information of the event available yet.The event date in unknown.Supplemental report(s) will be filed as the information becomes available.The device has been returned and a device evaluation completed for it.The manufacture date is not available.The user¿s complaint was confirmed.The device was tested and inspected.Worn out contact pins inside video connector are causing the image issues.Device passed all other functional tests.All video output signals tested okay.Conclusion of the evaluation was that worn out contact pins caused the image issues.

Event Description

As reported for this event during preparation for a therapeutic procedure, the device yielded intermittent image with any scope put in the camera port.The signal seemed to be getting lost with a loose connection.The image when available had lines shooting across the screen.There was no patient involvement.

Manufacturer Narrative

Additional information was received for this event.This supplemental report is being submitted to provide this information.Please see the updates in sections: e3, g4, g7, h2, h6, and h10.The event occurred when the patient was on the table but the surgeon was not yet in the room.The device was switched out for another similar device.There was no delay in the procedure and no adverse impact to the patient.The initial reporter title is bmet ii, clinical engineering.

Manufacturer Narrative

There is more information on the device evaluation.This supplemental report is being submitted to provide this information.The device history record review confirmed, that device had no abnormality in manufacturing.

• 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: 10030837
• MDR Text Key: 209224604
• Report Number: 8010047-2020-02496
• 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: other,user facility
• Type of Report: Initial,Followup,Followup
• Report Date: 11/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/06/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: CV-180
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/13/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1