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

Model Number CV-170

Device Problems No Display/Image (1183); Moisture Damage (1405)

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

Event Date 10/18/2021

Event Type  malfunction  

Manufacturer Narrative

The subject device is planned to be returned to olympus but has not been returned to olympus yet.However, the field service engineer of (b)(6) checked the subject device on-site and found the reported phenomenon, and also found that the user had done the fumigation of endoscopy room without taking out the subject device.The exact cause of the reported event could not be conclusively determined at this time.If additional information is received, this report will be supplemented.

Event Description

Olympus medical systems corp.(omsc) was informed from the user that during the inspection before the use, it was found that the endoscopic image of the subject device was not displayed and just a rectangle was displayed on the monitor.The field service engineer of olympus medical systems (b)(6) checked the subject device on-site and found that there were rust, dust, and moisture on the board of the subject device.There was no report of patient injury associated with this event.

Manufacturer Narrative

The subject device is planned to be returned to olympus but has not been returned to olympus yet.However, the field service engineer of (b)(4) checked the subject device on-site and found the reported phenomenon, and also found that the user had done the fumigation of endoscopy room without taking out the subject device.The exact cause of the reported event could not be conclusively determined at this time.If additional information is received, this report will be supplemented.

Event Description

Olympus medical systems corp.(omsc) was informed from the user that during the inspection before the use, it was found that the endoscopic image of the subject device was not displayed and just a rectangle was displayed on the monitor.The field service engineer of olympus medical systems (b)(4) checked the subject device on-site and found that there were rust, dust, and moisture on the board of the subject device.There was no report of patient injury associated with this event.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final 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 3 years since the subject device was manufactured.Based on the results of the investigation, the reported phenomena likely occurred because the examination room of endoscope was fumigated without removing the device.A definitive root cause cannot be identified.Olympus will continue to monitor the field performance of this device.

• Brand Name: 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: 12791672
• MDR Text Key: 285748484
• Report Number: 8010047-2021-14448
• Device Sequence Number: 1
• Product Code: FET
• UDI-Device Identifier: 04953170338502
• UDI-Public: 04953170338502
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K122831
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CV-170
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/10/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2019
• 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