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

Model Number CV-180

Device Problem Failure to Power Up (1476)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/27/2021

Event Type  malfunction  

Manufacturer Narrative

The suspect device was returned to olympus and evaluated.The reported problem was confirmed and the cause assigned to a failed power supply.The investigation is ongoing and the root cause of the reported event cannot be determined at this time.If additional information becomes available, this report will be supplemented accordingly.

Event Description

A user facility reported to olympus that the olympus, model cv-180, evis exera ii video system center, failed to power on.There was no patient injury, associated with the problem, reported to olympus.

Event Description

The problem, as reported to olympus, was identified during preparation for use.The intended procedure was a diagnostic endoscopic ultrasound and was cancelled.A delay in procedure occurred due to the problem; there was no adverse health effect the patient that occurred attributed to the delay.

Manufacturer Narrative

This supplemental report is submitted to provide additional event related information.

Manufacturer Narrative

This report is being supplemented, to provide additional information, based on the legal manufacturer's investigation.A review of the device history record found no deviations, that could have caused or contributed to the reported issue.It has been over 14 years, since the subject device was manufactured.Based on the results of the legal manufacturer's investigation, the root cause of the faulty power supply unit could not be identified.Olympus will continue to monitor field performance for this 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
• Manufacturer Contact: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 13338602
• MDR Text Key: 295413098
• Report Number: 8010047-2022-01904
• Device Sequence Number: 1
• Product Code: FAJ
• UDI-Device Identifier: 04953170215513
• UDI-Public: 04953170215513
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K133538
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date: 03/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/24/2022
• 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: 01/07/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/25/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/13/2008
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1