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

Model Number UHI-4

Device Problem Inflation Problem (1310)

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

Event Date 01/05/2023

Event Type  malfunction  

Event Description

The olympus representative reported for the customer that during a therapeutic laparoscopic cholecystectomy procedure, the high flow insufflation unit did not provide any air supply.The intended procedure was completed with a similar device.The patient was not under sedation, and there were no reports of patient harm associated with this event.

Manufacturer Narrative

The subject device referenced in this report was not returned for evaluation, therefore the device evaluation could not be completed at this time.The investigation is ongoing, and follow-up with the user facility is currently being performed.A supplemental report will be submitted upon completion of the investigation.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information from the customer.

Event Description

Additional information was supplied by the customer.At that time, the patient was not under sedation, so the procedure was stopped due to the failure of the subject device.After coordinating for another similar device to be used, the procedure was delayed by 2.5 hours.There was no patient harm reported.

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 since the device was not returned, the phenomenon was not duplicated during device evaluation.Therefore, the root cause of the phenomenon could not be identified.It is likely that high insufflation unit did not provide any air supply occurred due to errors in operation, poor gas supply, troubles after insufflation tube, and malfunctions inside the device based on the service manual.Per the service manual, possible cause of the insufflation were the following: "·operating errors ·air supply switch not pressed ·gas supply failure ·the valve of co2 cylinder is closed ·empty co2 cylinder ·high-pressure hose or hose for medical gas piping not connected ·co2 cylinder is lying ·problems after the insufflation tube ·pneumoperitoneum tube is not connected ·have a collapsed pneumoperitoneum tube ·there is a hole in the pneumoperitoneum tube ·the cock of the pneumoperitoneum needle is closed ·the cock of the tracker is closed ·pneumoperitoneum needle is not correctly stabbed ·poor pneumoperitoneum needle ·have a pneumoperitoneum for a narrow space ·be filled with filters ·malfunction inside the device ·disconnection of the tube in the device ·disconnection/disconnection of main pcb and harness of each valve ·failure of the electro-pneumatic proportional valve ·manifold (solenoid valve) failure ·failure of the main pcb ·1st regulator unit failure" 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: 16250825
• MDR Text Key: 309038984
• Report Number: 3002808148-2023-00833
• 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,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 03/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/26/2023
• 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?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/21/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/27/2019
• 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