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

Model Number CV-190

Device Problems No Display/Image (1183); Moisture Damage (1405)

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

Event Date 10/31/2023

Event Type  malfunction  

Manufacturer Narrative

The device was returned to olympus for evaluation and the customer's allegation was confirmed.There is a loose scope socket mechanical lock on the video connector socket that does not secure any paddles (or camera heads).All the paddles were loose and disconnected, when slightly moved caused noise or loss of image.The additional findings were as follows: that the power switch needed to be replaced due to a substance spilling on it.The unit was cracked and damaged on the front panel, the top cover needs to be replaced due to poor appearance, and a software 3.01.00 upgrade was needed.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or if any additional information is provided by the user facility.

Event Description

The customer reported to olympus that the video system center had no image.The issue was found at maintenance.There were no reports of patient involvement or 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 7 years, since the subject device was manufactured.A definitive root cause could not be determined, for the events reported.Based on the results of the investigation, about the "no image".It is likely, the following led to the malfunction loosening of the scope socket.And for "the material spilled" event, there is not any probable cause.Olympus will continue to monitor field performance for this device.

• Brand Name: EVIS EXERA III 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: 18156880
• MDR Text Key: 329777477
• Report Number: 3002808148-2023-13015
• Device Sequence Number: 1
• Product Code: FET
• UDI-Device Identifier: 04953170298622
• UDI-Public: 04953170298622
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131780
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 01/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CV-190
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/06/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/21/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/28/2015
• 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