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

Model Number CV-180

Device Problems Poor Quality Image (1408); Failure to Power Up (1476)

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

Event Date 11/23/2021

Event Type  malfunction  

Manufacturer Narrative

The subject device was returned to the olympus local service department.The olympus local service department checked the subject device and found the following events.- due to failure of the circuit board, the screen showed vertical line noise and the endoscopic image of the subject device could not be seen.- due to failure of the power supply unit, the subject device could not be turned the power on.A supplemental report will be submitted, if additional or significant information becomes available at a later time.

Event Description

Olympus medical systems corp.(omsc) was informed from the nurse that during the preparation for use, the button of the front panel of the subject device did not work.Other detailed information was not provided.There was no report of patient injury associated with the event.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information.Device history record review indicates that the product was manufactured and tested in accordance with all applicable procedures and met all final product release criteria.Based upon the information from the olympus local service department, olympus medical systems corp.(omsc) surmised that the reported phenomenon occurred due to the following causes.Due to failure of the power supply unit, the button of the front panel of the subject device did not work (and the subject device could not be turned the power on).The exact cause of the power supply unit failure could not be conclusively determined.Due to failure of the circuit board, the screen showed vertical line noise and the endoscopic image of the subject device could not be seen.The exact cause of the circuit board failure could not be conclusively determined.

• 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: 13016255
• MDR Text Key: 285737931
• Report Number: 8010047-2021-16238
• Device Sequence Number: 1
• Product Code: FAJ
• UDI-Device Identifier: 04953170215513
• UDI-Public: 04953170215513
• Combination Product (y/n): N
• Reporter Country Code: VM
• PMA/PMN Number: K133538
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 01/18/2022

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 Model Number: CV-180
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/23/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/23/2021
• Initial Date FDA Received: 12/16/2021
• Supplement Dates Manufacturer Received: 12/23/2021
• Supplement Dates FDA Received: 01/17/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/14/2010
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1