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

Model Number CV-180

Device Problem Poor Quality Image (1408)

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

Event Type  malfunction  

Manufacturer Narrative

The device has not been returned to omsc but was returned to olympus repair center in hamburg for evaluation.Olympus repair center inspected the device and confirmed the following; the reported phenomenon was not reproduced.The endoscopic image was displayed, but due to a failure of the printed circuit board, the dark areas of the image were displayed in blue or red, and the bright areas of the image gradually faded.The rear panel, chassis, and power supply unit were corroded.The locking lever of the video connector socket was damaged but could be connected.This defect may have been caused by excessive stress on the video connector socket.The storage battery ran out.The exact cause of the reported event could not be conclusively determined, because the device has not been returned to omsc.More than four years have passed since the device was manufactured.Omsc concluded that the failure of the video connector socket caused unstable contact between the electrical contacts of the connector, which hindered image transmission between the endoscope and the video system center and prevented the endoscope image from being displayed properly.Device history record (dhr) review indicates that the product was manufactured and tested in accordance with all applicable procedures and met all final product release criteria.If additional information becomes available, this report will be supplemented.

Event Description

Olympus medical systems corp.(omsc) was informed by the user that the endoscopic image gradually faded and could not be seen anything.There was no report of patient injury associated with the event.

• 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: 11606921
• MDR Text Key: 246117826
• Report Number: 8010047-2021-04495
• Device Sequence Number: 1
• Product Code: FAJ
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K133538
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/02/2021

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: No Information
• Device Model Number: CV-180
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/08/2021
• Initial Date FDA Received: 04/02/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/20/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1