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

Model Number CV-180

Device Problem Display or Visual Feedback Problem (1184)

Patient Problem No Patient Involvement (2645)

Event Date 11/09/2020

Event Type  malfunction  

Manufacturer Narrative

The unit was returned to the service center for evaluation.The customer¿s complaint of ¿ there is no image and 1/4 of an image was black image.Happens as soon as scope is connected¿ could not be duplicated.The units electronics were inspected and found an issue with the ap board due to a faulty printed circuit board.The unit's software version is version 4.0.The investigation is ongoing and if additional information is received this report will be supplemented accordingly.

Event Description

The service center was informed that during preparation for use, when the scope was connected to the video system a portion of the image appeared black on the display.There was no patient involvement reported.

Manufacturer Narrative

This supplemental report is being submitted to provide the legal manufacturer investigation and additional information from the customer.Additional information received from the facility¿s material manager states the event diagnostic flex sigmoid.The connection was secure.The settings were correct.There were no foreign objects observed on the electrical contacts.There was no damage or abnormalities observed with the device prior to preparation.There were no error codes, messages, warnings, alerts or alarms received.The patient was under anesthesia about 10-15 minutes longer.The unit was switched out and the intended procedure was completed.There was no patient injury.In addition, the legal manufacturer (lm) reviewed the content of this complaint for further investigation.The legal manufacturer was unable to determine the root cause.As the results of the dhr review, it was confirmed that there was no abnormality in manufacturing, concession, and variation.It was confirmed that there was no unevenness.The lm reported that the most probable cause for the reported event is as follows: since it was not reproduced in the repair section, it was assumed that the said equipment was broken due to aging because there was no abnormality in the said equipment, there was a problem in either of the other devices (scope, scope cable), or the scope was functioning correctly on the loner machine (another cv-180).Since there are various abnormalities in the image, in the case of failure, the ap substrate which is performing analog signal processing is suspected.

• 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
• MDR Report Key: 11251112
• MDR Text Key: 231659398
• Report Number: 8010047-2021-02000
• Device Sequence Number: 1
• Product Code: FAJ
• UDI-Device Identifier: 04953170215513
• UDI-Public: 04953170215513
• Combination Product (y/n): N
• PMA/PMN Number: K133538
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 03/04/2021

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: Health Professional
• Device Model Number: CV-180
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/16/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/04/2021
• Initial Date FDA Received: 01/29/2021
• Supplement Dates Manufacturer Received: 02/03/2021
• Supplement Dates FDA Received: 03/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1