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

Model Number CV-180

Device Problem No Display/Image (1183)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  Malfunction  

Manufacturer Narrative

The suspect device was returned to olympus and evaluated. The reported problem was not confirmed. The video image was verified to function normally. A definitive root cause could not be determined.

Event Description

The user facility reported to olympus that the device failed to produce an image. The problem, as reported to olympus, occurred during a procedure. There was no patient injury or harm, associated with the problem, reported to olympus.

• 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: 10556453
• MDR Text Key: 222090198
• Report Number: 8010047-2020-06685
• Device Sequence Number: 1
• Product Code: FAJ
• 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: USER FACILITY

Reporter Occupation

• Type of Report: Initial
• Report Date: 09/18/2020

1 Device Was Involved in the Event

0 PatientS WERE Involved in the Event:

• Date FDA Received: 09/18/2020
• 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: 09/06/2020

Is The Reporter A Health Professional?

• Was the Report Sent to FDA?: No
• Event Location: No Information
• Date Manufacturer Received: 08/26/2020
• Was Device Evaluated By Manufacturer?: Yes
• Is The Device Single Use?: No
• Is this a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse