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

Model Number CV-170

Device Problem Connection Problem (2900)

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

Event Date 02/21/2024

Event Type  malfunction  

Manufacturer Narrative

The device evaluation is ongoing.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported the video system center had a connection problem.The issue occurred during preparation for use for a diagnostic endoscopic examination procedure.The patient was not under anesthesia at the time and the procedure was cancelled and rescheduled.There were no reports of patient harm.

Manufacturer Narrative

This supplemental report is being submitted to provide the results of the legal manufacturer's final investigation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 5 years since the subject device was manufactured.Based on the results of the investigation, and since the device malfunction was not confirmed during evaluation, the definitive root cause of the reported issue could not be determined.Olympus will continue to monitor field performance for this device.

• Brand Name: 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 961-8 061; JA 961-8061
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 18970768
• MDR Text Key: 338758038
• Report Number: 3002808148-2024-02838
• Device Sequence Number: 1
• Product Code: FET
• UDI-Device Identifier: 04953170338496
• UDI-Public: 04953170338496
• Combination Product (y/n): N
• Reporter Country Code: EN
• PMA/PMN Number: K122831
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 03/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CV-170
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/05/2024
• Was Device Evaluated by Manufacturer?: No
• 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