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 02/01/2023

Event Type  malfunction  

Manufacturer Narrative

The device was returned to an olympus repair facility, and an evaluation of the device was performed.During the evaluation, the customer's originally reported issue that the device produced sounds of a gas leakage was not confirmed.The reported sounds could not be reproduced.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.

Event Description

The customer reported that, upon starting the use of the device during a laparoscopy, the customer¿s high flow insufflation unit made an abnormal noise that sounded like air was leaking.The customer was able to finish the procedure successfully using a different device, with no negative outcomes associated with the issue.No accessories were in use.There were no reports of patient or user harm associated with this event.

Manufacturer Narrative

This report is being supplemented to provide additional information based on 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.Based on the results of the investigation, and because the phenomenon was not duplicated during device evaluation, the root cause of the phenomenon could not be identified.From the service manual, possible reasons for the abnormal noise occurs while the device is stopped are as below: ·the case in which abnormal noise occurs while the device is stopped.·gas leakage at high pressure parts ·coming off of the tube in the device ·the case in which abnormal noise occurs while sending air ·failure of the primary decompressor ·failure of the electropneumatic proportional valve ·failure of the manifold 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: 16478313
• MDR Text Key: 310964507
• Report Number: 3002808148-2023-02041
• Device Sequence Number: 1
• Product Code: HIF
• UDI-Device Identifier: 04953170324147
• UDI-Public: 04953170324147
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K122180
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/03/2023
• 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
• Date Returned to Manufacturer: 02/07/2023
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/15/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/30/2016
• 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