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

Model Number UHI-4

Device Problems Increase in Pressure (1491); Free or Unrestricted Flow (2945); Fail-Safe Did Not Operate (4046)

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

Event Date 11/20/2022

Event Type  malfunction  

Event Description

The customer reported to olympus that while using the high flow insufflation unit, there was increase in measurement value, and the alarm sounded and resolved spontaneously after 1 to 2 minutes.When the alarm occurred, the pressure setting read 48 mmhg against the abdominal cavity pressure setting of 8 mmhg.The issue occurred during a therapeutic (laparoscopic) procedure, and the procedure was completed with the same set of equipment.There was no patient harm associated with the event.

Manufacturer Narrative

The device was returned and evaluated, and the customer¿s allegation could not be confirmed.The investigation is ongoing, and a supplemental report will be submitted upon completion of the investigation or if any additional information is provided by the user facility.

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.The following operations were performed using the asset cylinder and cavity model but could not confirm the phenomenon.One hour aging test.Manually applied pressure during insufflation, and checked error.Error occurred as designed.Decreased air pressure and checked insufflation.Pressure started to increase as designed.Repeatedly turned on/off the power.There was no abnormality in manufacturing history.Olympus will continue to monitor field performance for this device.

Manufacturer Narrative

This report is being supplemented to correct the h6 problem code and to provide additional information in h7/h9.A formal investigation was initiated to investigate the root cause.

• 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: 15997679
• MDR Text Key: 308190878
• Report Number: 3002808148-2022-05327
• Device Sequence Number: 1
• Product Code: HIF
• UDI-Device Identifier: 04953170324147
• UDI-Public: 04953170324147
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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
• Reporter Occupation: Biomedical Engineer
• Remedial Action: Relabeling
• Type of Report: Initial,Followup,Followup
• Report Date: 12/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2022
• 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: 12/01/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/16/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/31/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: Z-0075-2024
• Patient Sequence Number: 1