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

The suspect device was returned to olympus for evaluation.The reported problem could not be confirmed.When tested, the device produced an image with no problems noted.However, a worn lock latch mechanism inside the video connector was found, which could cause image related issues.

Event Description

A user facility reported to olympus that the olympus cv-180 did not produce an image after scopes were connected.The problem, as reported to olympus, was found on preparation for use.There was no patient injury or harm, associated with the problem, reported to olympus.

Manufacturer Narrative

This supplemental report is submitted to provide additional event related information.Update to section b5 and h6.

Event Description

The problem, as reported to olympus by the user facility, was found upon arrival/unpacking.

Manufacturer Narrative

This supplemental report is submitted to provide the results of the legal manufacturer¿s investigation and device history record (dhr) review.Updates to sections d4, h4 and h6.The dhr for the subject device was reviewed and it was verified the device was manufactured in accordance with documented specifications.The legal manufacturer performed an investigation.A conclusive root cause was not identified.The legal manufacturer determined the likely cause of the no image was a problem associated with other equipment used in combination with the subject device or due to the worn lock latch, resulting in the reported phenomenon in which no image appeared.The likely cause of the worn lock latch, identified on the device evaluation, was repeated use and the age of the 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: 10617342
• MDR Text Key: 210078422
• Report Number: 8010047-2020-07097
• 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: user facility
• Type of Report: Initial,Followup,Followup
• Report Date: 01/08/2021

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: 09/15/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/08/2020
• Initial Date FDA Received: 10/01/2020
• Supplement Dates Manufacturer Received: 10/06/2020; 12/15/2020
• Supplement Dates FDA Received: 10/07/2020; 01/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1