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

Model Number UHI-4

Device Problems Inaccurate Flow Rate (1249); Gas/Air Leak (2946)

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

Event Date 10/02/2023

Event Type  malfunction  

Manufacturer Narrative

The device was returned to olympus for evaluation and the customer¿s allegation was confirmed.The air belly flow rate decreased due to a gas leakage.Although the air belly flow rate is normally set at eight (8), the flow rate was lowered.Attempts to retrieve additional information from the customer are in progress.This event is under investigation.A supplemental report will be submitted upon receiving additional information.

Event Description

The customer reported to olympus that during a case of endoscopic colon surgery, the high flow insufflation unit pneumoperitoneum flow rate of the uhi-4 was not stable, and although this flow rate is normally set at 8, the flow rate decreased.The flow rate never rose above the setting.Additionally, smoke emissions occurred at unintended times.The procedure was completed with the same device and there was no patient harm or effects on the patient 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, a definitive root cause could not be established.The suggested phenomenon of "pneumoperitoneum flow was usually set at 8, but the flow rate had fallen" was presumed to have been due to a combination of equipment such as a trocar, causing the pressure to drop quickly, or the insufflation tip volume to be small, causing instability in pneumoperitoneum maintain.The suggested phenomenon of "reduced flow due to gas leakage" was not reproduced.A further cause of this suggested event could therefore not be presumed.The instructions for use (ifu) gt7589 12th edition 5.14 of uhi-4 includes the following: "5.14 automated suction function is a function in which an automatic suction is performed when the cavity pressure exceeds 5mmhg for the set pressure for more than 10 seconds until the cavity pressure falls to the set pressure." 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: 18049690
• MDR Text Key: 327139510
• Report Number: 3002808148-2023-12114
• 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,User Facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 11/16/2023

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
• Date Returned to Manufacturer: 10/09/2023
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/05/2023
• Initial Date FDA Received: 11/01/2023
• Supplement Dates Manufacturer Received: 11/10/2023
• Supplement Dates FDA Received: 11/16/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/25/2022
• 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
• Treatment: MAJ-1939 SERIAL NO.(B)(6).