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

Model Number CV-180

Device Problems Erratic or Intermittent Display (1182); Poor Quality Image (1408)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/12/2020

Event Type  Malfunction  

Manufacturer Narrative

The device was returned to olympus repair center for evaluation. The evaluation of the device confirmed followings; defects of the circuit boards were noted. The reported events were caused by the defects. Rusts were found around the rear panel connector, part of the interior, and part of the circuit board. Due to the defects of the circuit boards, the buzzer did not sound when the key on the front panel was pressed. If additional information becomes available, this report will be supplemented.

Event Description

The user facility said that the endoscopic image was intermittent. Then, during the evaluation of the device by olympus, the endoscopic image became black and white when the picture-in-picture function was on. There was no report of patient injury associated with this 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: 10660258
• MDR Text Key: 223663054
• Report Number: 8010047-2020-07538
• Device Sequence Number: 1
• Product Code: FAJ
• Combination Product (Y/N): N
• Reporter Country Code: IN
• PMA/PMN Number: K133538
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: HEALTH PROFESSIONAL

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 12/15/2020

1 Device Was Involved in the Event

0 PatientS WERE Involved in the Event:

• Date FDA Received: 10/11/2020
• 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?: Yes
• Is The Reporter A Health Professional?: No
• Was the Report Sent to FDA?: No
• Event Location: No Information
• Date Manufacturer Received: 11/17/2020
• Was Device Evaluated By Manufacturer?: Device Not Returned To Manufacturer
• Date Device Manufactured: 11/04/2010
• Is The Device Single Use?: No
• Is this a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse