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 Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

The device was evaluated by olympus.The technician performed full inspection on the unit.It was noted a broken pin was stuck inside the pip connector on the front panel, possibly caused by excessive stress to the video connector socket.In addition, there was cosmetic wear on front panel and dust inside unit, however this does not affect fit and functionality of unit.All components of the device were repaired and cleaned.The device was inspected to olympus functional standard and electrical safety check in accordance with olympus standards.The investigation is ongoing; therefore, the root cause of the reported event cannot be determined at this time.However, if additional information becomes available this report will be supplemented accordingly.

Event Description

It was reported a evis exera iii video system center was being prepared for use.During the prep the center pin for the cable that connects to the controller to the ultrasound unit broke off inside the connector experienced image processor connector issues.No additional information has been provided.No impact to patient.

Manufacturer Narrative

The following fields were updated: d4, g4, g7, h2, h4, h6, h10.This supplemental report is being submitted to provide the results of the manufacturer¿s investigation.The device evaluation, a review of the device history record (dhr), and a review of the instructions for use (ifu) were conducted during this investigation.As stated on the initial report "it was noted a broken pin was stuck inside the pip connector on the front panel, possibly caused by excessive stress to the video connector socket.In addition, there was cosmetic wear on front panel and dust inside unit, however this does not affect fit and functionality of unit.All components of the device were repaired and cleaned." the review of the dhr did not find any abnormalities or anomalies identified during production.The device met all specifications upon release.The ifu contains the following statements: ¿do not apply excessive force to the video system center and/or other instruments connected.Otherwise, damage and/or malfunction can occur.¿ the root cause could not be determined.However, it is speculated that the event occurred because the user did not notice the description in the instructions for use, and due to the application of excessive force to the connectors.Olympus will continue to monitor the field performance of this device.

• 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: 10960644
• MDR Text Key: 226933444
• Report Number: 8010047-2020-09953
• 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: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 01/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: CV-190
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/28/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1