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

Model Number CV-190

Device Problem Device Damaged Prior to Use (2284)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The device was not returned to olympus and an evaluation cannot be performed at this time.

Event Description

A user facility reported to olympus that the video olympus, cv-190, scope socket was damaged, found on setup of the device for a procedure.The intended procedure is unknown.There was no patient injury or harm, associated with the problem, reported to olympus.

Manufacturer Narrative

This supplemental report is submitted to provide the results of the legal manufacturer¿s investigation and device history record (dhr) review.The dhr was reviewed for the subject device.No anomalies were noted and it was verified the device was manufactured in accordance with documented specifications and procedures.The legal manufacturer performed an investigation.A conclusive root cause could not be determined.Possible causes, as determined by the legal manufacturer, include deterioration due to the age of the device or due to user handling.

• Brand Name: EVIS EXERA III 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: 10201648
• MDR Text Key: 199716408
• Report Number: 8010047-2020-03684
• Device Sequence Number: 1
• Product Code: FET
• Combination Product (y/n): N
• PMA/PMN Number: K131780
• 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: 10/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/26/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CV-190
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1