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

Model Number UHI-4

Device Problems No Display/Image (1183); Improper Flow or Infusion (2954)

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

Event Date 08/22/2022

Event Type  malfunction  

Event Description

The field service engineer (fse) reported on behalf of the customer, that the display turned off, all light-emitting diode (led) buttons disappeared, and the alarm sound was unclear when the high flow insufflation unit was turned on during routine inspection.According to the customer, after some time, the device will work fine but the issue persisted.Additional information has been requested regarding the persistence of the issue and the information is currently pending.During testing and inspection of the returned device, the flow rate was not being maintained properly due to a faulty manifold and regulator unit.There was no patient or procedure involvement.

Manufacturer Narrative

An olympus field service engineer checked the device and found the same problem.There was an alarm sound and the alarm leds were not glowing when the device was turned on.During device evaluation at olympus, it was found the display disappeared with a beep sound due to a faulty circuit board.The low rate was not maintained properly due to a faulty manifold and regulator unit.The alarm sound being unclear was not confirmed.Additionally, it was found the tracks of the flat cable between the circuit board and front panel and the electropneumatic proportional valve were rusted.Scratches, corrosion and rust were found on several parts on the outside of the device.This event is under investigation.A supplemental report will be submitted upon receiving additional information.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the approved 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, the definitive root cause of the faulty circuit board, faulty manifold unit, and faulty first regulator could not be determined.Olympus will continue to monitor field performance for this device.

Manufacturer Narrative

This report is being supplemented to provide additional information obtained regarding this event, refer to b5.

Event Description

It has been previously reported that after some time, the device will would fine but the issue persisted.Clarification was provided from the customer.The issue was intermittent during the same event.The device did not have this issue in addition to this event.There were no additional occurrences.

• 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: 15460811
• MDR Text Key: 306332189
• Report Number: 3002808148-2022-02238
• 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,Followup
• Report Date: 02/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/21/2022
• 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: 01/19/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/24/2016
• 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