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

Model Number CV-180

Device Problem Poor Quality Image (1408)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/08/2020

Event Type  malfunction  

Manufacturer Narrative

The device was not returned to olympus for evaluation.Troubleshooting was performed and the reporter was advised to check various setting, however, the reporter was not able to complete troubleshooting during the phone call.The reporter indicated they would call back if the issue persists to continue troubleshooting.Multiple attempts to contact the customer were made with no response.As the device was not returned for evaluation, we are unable to determine a root cause for the reported event.If additional information becomes available or the device is returned for evaluation, a supplemental report will be filed.

Event Description

The user facility reported that the image is freezing when attempting to capture images from the cv-180 to provation.Customer jonathan lui called in reporting that when the customer attempts to capture images from the cv-180 to provation platform.There was no patient harm reported for this report.

Manufacturer Narrative

This supplemental report is being submitted to provide the additional information from the legal manufacturer regarding the final investigation.The legal manufacturer (lm) reviewed the content of this complaint for further investigation.As a result of the dhr review, there were no abnormality in manufacturing, concession, and variation.The legal manufacturer reported that the unit was delivered to the customer on : march 18, 2009.The legal manufacturer reported that the root cause could not be determined.The lm reported that the most probable causes for the reported event are as follows: because the frozen image was not reproduced, it was presumed that there was no problem with the subject product, but the problem in other devices (endoscopes, endoscope cables) than the subject product, or it is presumed that the user pushed the endoscope switch which was set to freeze trying to capture the image.Regarding no image sent to probation, it is presumed that it was caused by setting of the subject product or probation, or an incorrect cable connection.

• 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: 10626569
• MDR Text Key: 209802530
• Report Number: 8010047-2020-07216
• 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: 01/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2020
• 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: 12/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1