MAUDE Adverse Event Report: SHIRAKAWA OLYMPUS CO., LTD. EVIS X1 VIDEO SYSTEM CENTER

Model Number CV-1500

Device Problem Moisture Damage (1405)

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

Event Date 09/14/2023

Event Type  malfunction  

Manufacturer Narrative

This video processor was returned to olympus for evaluation and the customers allegation was confirmed.In addition to the reportable findings documented in b5, the following nonreportable finding was; error code e117 a component needs to be replaced.This investigation is still ongoing.A supplemental report will be submitted upon completion of the investigation or if any further information is provided by the user facility.

Event Description

The customer reported to olympus, during a pre procedure inspection, the video processor endo socket was flooded with water.The device was returned for evaluation and during the evaluation it was determined that the following reportable events were identified; no proper image due to liquid spill damage.There was no report of patient harm.Further follow up information has been requested from the customer.This medical device report (mdr) is being submitted to capture the reportable malfunction found during evaluation.

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 one (1) year since the subject device was manufactured.Based on the results of the investigation, it is not possible to establish the root cause.However, it is likely that scope connection failure occurred and "no image" occurred because liquid fell on output connector and scope contact was corroded and malfunctioned.Olympus will continue to monitor field performance for this device.

• Brand Name: EVIS X1 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: 17908435
• MDR Text Key: 325353268
• Report Number: 3002808148-2023-11057
• Device Sequence Number: 1
• Product Code: FET
• UDI-Device Identifier: 04953170414596
• UDI-Public: 04953170414596
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K222861
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/16/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/10/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CV-1500
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/22/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/04/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/16/2022
• 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