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

Model Number CV-180

Device Problem Erratic or Intermittent Display (1182)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/16/2020

Event Type  Malfunction  

Manufacturer Narrative

The subject device in this report has not been returned to omsc for evaluation. The exact cause of the reported event could not be conclusively determined at this time. If additional information becomes available, this report will be supplemented.

Event Description

Olympus medical systems corp. (omsc) was informed from the user that during unspecified procedure, the endoscopic image of the subject device intermittently flickered. It appeared if the endoscope was removed the issue was fixed. The user completed the procedure with the subject device. 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: 10858982
• MDR Text Key: 225930584
• Report Number: 8010047-2020-09079
• Device Sequence Number: 1
• Product Code: FAJ
• Combination Product (Y/N): N
• Reporter Country Code: AS
• PMA/PMN Number: K133538
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: FOREIGN,HEALTH PROFESSIONAL,U
• Reporter Occupation: BIOMEDICAL ENGINEER
• Type of Report: Initial,Followup
• Report Date: 01/08/2021

1 Device Was Involved in the Event

0 PatientS WERE Involved in the Event:

• Date FDA Received: 11/18/2020
• 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: 10/20/2020
• Is The Reporter A Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Event Location: No Information
• Date Manufacturer Received: 12/25/2020
• Was Device Evaluated By Manufacturer?: Yes
• Date Device Manufactured: 06/09/2010
• Is The Device Single Use?: No
• Is this a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unkown