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

Model Number UHI-4

Device Problems Contamination (1120); Loss of Power (1475); Pressure Problem (3012); Failure to Clean Adequately (4048)

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

Event Date 08/30/2022

Event Type  malfunction  

Manufacturer Narrative

The device was returned.The investigation is ongoing and a supplemental will be submitted on completion of investigation or if any additional information is available.

Event Description

The customer reported to olympus, the high flow insufflation unit did not insufflate and turned off during preparation for use for a diagnostic laparoscopy procedure.The procedure was postponed.The device was returned to the distributor, and it was noted the insufflator had immersion of an unknown liquid in the hose.There were no reports of patient harm associated with the event.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation and device evaluation.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, there was internal liquid in the hoses, and the equipment did not properly inflate.The insufflation issue was caused by a faulty gas regulator.However, the definitive root cause of the faulty gas regulator and internal liquid could not be determined.The instruction manual identifies the following verbiage, which may have prevented the phenomenon: ¿position the patient port of the insufflator and as much of the associated tubing as is practical above the insufflation site, to prevent patient fluids from inadvertently entering the tubing.Placing the tubing below the insufflation site may cause patient fluid to drain into the insufflator due to gravity.If blood and body fluid penetrate inside the insufflation tube that is connected to the high-flow insufflation unit, be careful not to bring the insufflation tube at a higher level than the co2 feed port of the insufflation unit when disconnecting the tube from the veress needle or trocar or cabg applicator.Otherwise, the blood and body fluid may enter the insufflation unit and contaminate it.·when relief mode is set to on, the intra-cavity gas will flow backward into the equipment for relief through the built-in valve.To prevent the internal surfaces of the equipment from being contaminated, be sure to use a disposable filter.When no filter is used, make sure relief mode is set to off.·when relief mode is set to on, the relief function will operate if an additional veress needle or trocar, etc.Is inserted (due to the momentarily high cavity pressure).To disable the relief function, press the stop switch.¿ olympus will continue to monitor field performance for this device.

Manufacturer Narrative

This report is being submitted for correction to d9.Please see updates to h10 regarding additional information based on device evaluation.The device evaluation was completed.Visual inspection revealed minor scrape/chip mark on the upper left corner of front panel but the front panel was functional.Noted that no corrosion on rear panel, bottom chassis, housing, cablings.Printed circuit board components appeared to be intact.In addition, the device was also been inspected by service line.The unknown fluid invasion could have contributed to the inflation failure.If any additional information is received, the report will be supplemented.

• Brand Name: HIGH FLOW INSUFFLATION UNIT
• Type of Device: LAPAROSCOPIC INSUFFLATOR
• Manufacturer (Section D): SHIRAKAWA OLYMPUS CO., LTD.; 3-1 okamiyama; odakura, nishigo-mura; nishishirakawa-gun, fukushima 961-8 061; JA 961-8061
• Manufacturer Contact: masaharu hirose ; 3-1 okamiyama; odakura, nishigo-mura,; nishishirakawa-gun, fukushima 961-8-061 ; JA 961-8061 ; 426422891
• MDR Report Key: 15520626
• MDR Text Key: 306340215
• Report Number: 3002808148-2022-02640
• Device Sequence Number: 1
• Product Code: HIF
• UDI-Device Identifier: 04953170324147
• UDI-Public: 04953170324147
• Combination Product (y/n): N
• Reporter Country Code: CS
• 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,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 12/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2022
• 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: 09/27/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/21/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/06/2018
• 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