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

Model Number UHI-4

Device Problems Display or Visual Feedback Problem (1184); Leak/Splash (1354)

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

Event Date 08/18/2022

Event Type  malfunction  

Manufacturer Narrative

The reported allegation of front panel lights turning off was confirmed during device inspection and was due to defective pressure sensor circuit board which was rusted; however, the allegation of unclear alarm sound was not confirmed.Electro pneumatic valve was rusted.Flat cable connecting the sensor circuit board and front panel was also rusted.External condition of the device was evaluated and the following findings were reported.There were hit and scratches marks on front panel.Front panel was yellowish and there were scratches on top cover.Rust and corrosion was found on the rear panel.The chassis was corroded.Main switch was making abnormal sound intermittently.Foot switch connector and potential equalizer was also rusted.The investigation is on-going and a supplemental will be submitted upon completion of investigation or if any additional information is available.

Event Description

The customer reported to olympus, after switching on the power source of the high flow insufflation unit during routine inspection, the alarm was generated and the front panel lights were turned off.The alarm sound was unclear and the issue happened repeatedly.The device was returned and it was noted there was leakage of the connector unit and moisture condensation inside the regulator unit due to leakage of the regulator unit.There was no patient involvement.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.It has been over 6 years since the subject device was manufactured.Based on the results of the legal manufacturer's investigation, (1) the phenomenon ¿front panel display is disappearing with a beep sound¿ was attributed to rusty patient circuit (cr) board.(2) since further information was not available, the cause of the phenomenon, ¿leaking from k-connector¿, could not be identified.(3) the phenomenon ¿the first regulator unit moisture found at inspection¿ was attributed to leaking inside the first regulator unit.A review of the device history record found no deviations that could have caused or contributed to the reported issue.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 Contact: masaharu hirose ; 3-1 okamiyama; odakura, nishigo-mura,; nishishirakawa-gun, fukushima 961-8-061 ; JA 961-8061 ; 426422891
• MDR Report Key: 15435571
• MDR Text Key: 306322090
• Report Number: 3002808148-2022-02094
• Device Sequence Number: 1
• Product Code: HIF
• UDI-Device Identifier: 04953170324147
• UDI-Public: 04953170324147
• Combination Product (y/n): N
• Reporter Country Code: IN
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/16/2022
• 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: 08/24/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/27/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/07/2016
• 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