MAUDE Adverse Event Report: SHIRAKAWA OLYMPUS CO., LTD. HIGH FLOW INSUFFLATION UNIT

Model Number UHI-4

Device Problem Gas/Air Leak (2946)

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

Event Date 02/13/2024

Event Type  malfunction  

Manufacturer Narrative

To date, the device has not been returned.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported, the insufflator was producing sound of gas leakage.The issue occurred during routine general inspection.There were no reports of patient harm.

Manufacturer Narrative

The device was returned and the evaluation found that gas was leaking from the faulty k connector unit, secondary piping leakage was no working properly due to faulty manifold unit.Should additional relevant information become available, a supplemental report will be submitted.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the device inspection, the legal manufacturer's final investigation, and associated h6 coding.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over four (4) years since the subject device was manufactured.The device was returned to olympus for inspection, and the customer's complaint was confirmed.Due to a faulty k connector, gas was leaking; due to a defective 1st regulator, a gas leak sound was heard; and due to a faulty manifold unit, secondary piping leakage occurred.Based on the results of the investigation, it is likely that the sound of gas leakage was due to a defective regulator, the secondary piping leakage was due to a faulty manifold, and the gas leakage was due to a defect of the k connector.Olympus will continue to monitor field performance for this device.

• Brand Name: HIGH FLOW INSUFFLATION UNIT
• Type of Device: HIGH FLOW INSUFFLATION UNIT
• 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: 18793306
• MDR Text Key: 337512843
• Report Number: 3002808148-2024-01843
• Device Sequence Number: 1
• Product Code: HIF
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K122180
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup,Followup
• Report Date: 04/05/2024

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: Health Professional
• Device Model Number: UHI-4
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/13/2024
• Initial Date FDA Received: 02/27/2024
• Supplement Dates Manufacturer Received: 03/05/2024; 03/28/2024
• Supplement Dates FDA Received: 03/06/2024; 04/05/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/29/2019
• 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