MAUDE Adverse Event Report: SHIRAKAWA OLYMPUS CO., LTD. EVIS EXERA II VIDEO SYSTEM CENTER

Model Number CV-180

Device Problem No Display/Image (1183)

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

Event Type  malfunction  

Manufacturer Narrative

The device was returned, and the evaluation found no malfunctions aside from the allegation reported in b5.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was observed that during the device evaluation, the video system center exhibited an intermittent image due to a faulty printed circuit board.There were no reports of patient involvement.

Manufacturer Narrative

This supplemental report is being submitted to provide the results of the legal manufacturer's final investigation.Additional information added to field h6.Corrected fields: d5.Since the device is more than 15 years old, the device history record was unable to be reviewed.However, olympus only releases products to market that meet all manufacturing specifications and final product release criteria.Based on the results of the investigation, it is likely the malfunction was caused by a failure of the printed circuit board.Olympus will continue to monitor field performance for this device.

• Brand Name: EVIS EXERA II VIDEO SYSTEM CENTER
• Type of Device: VIDEO SYSTEM CENTER
• Manufacturer (Section D): SHIRAKAWA OLYMPUS CO., LTD.; 3-1 okamiyama; odakura, nishigo-mura,; nishishirakawa-gun, fukushima 961-8 061; JA 961-8061
• Manufacturer (Section G): SHIRAKAWA OLYMPUS CO., LTD.; 3-1 okamiyama; odakura, nishigo-mura,; nishishirakawa-gun, fukushima
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 18843105
• MDR Text Key: 337675244
• Report Number: 3002808148-2024-02070
• Device Sequence Number: 1
• Product Code: FAJ
• UDI-Device Identifier: 04953170215513
• UDI-Public: 04953170215513
• 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: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 03/25/2024

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: Other
• Device Model Number: CV-180
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/16/2024
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/23/2024
• Initial Date FDA Received: 03/05/2024
• Supplement Dates Manufacturer Received: 03/19/2024
• Supplement Dates FDA Received: 03/25/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/10/2006
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1