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

Model Number UHI-4

Device Problem Power Problem (3010)

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

Event Date 02/28/2023

Event Type  malfunction  

Event Description

The customer reported that his nurse inspected his olympus high flow insufflation unit during procedure preparation and found it was experiencing a power issue.According to the initial reporter, after pressing the power button, the unit would turn on, the immediately turn itself off.Reportedly, a back-up unit was used to perform intended procedure.

Manufacturer Narrative

The device was returned, and an initial evaluation was conducted by olympus; however, investigation is ongoing.During the initial evaluation, the user¿s report was confirmed.A faulty printed circuit board was discovered.This board could no longer control it¿s functions and was causing the unit¿s alarm to sound.Additionally, the actual flow rate value could not reach the set flow rate due to the manifold unit being defective.If additional information becomes available following the device evaluation, a supplemental report will be filed.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.Correction to h4.Information was inadvertently not included on the initial medwatch.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 6 years since the subject device was manufactured.Based on the results of the investigation, and since the device malfunction of the power suddenly turning off was not confirmed during evaluation, the definitive root cause of the reported issue could not be determined.However, a probable cause is likely due to a faulty printed circuit board.Based on the results of the investigation, it is likely any function could not be controlled, and the alarm sound wouldn¿t stop occurred due to a fault printed circuit board.However, a definitive root cause could not be determined.Based on the results of the investigation, it is likely the actual flow rate value not reaching the setting flow rate value occurred due to a faulty manifold unit.However, a definitive root cause could not be determined.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: 16545530
• MDR Text Key: 311600845
• Report Number: 3002808148-2023-02512
• Device Sequence Number: 1
• Product Code: HIF
• UDI-Device Identifier: 04953170324147
• UDI-Public: 04953170324147
• Combination Product (y/n): N
• Reporter Country Code: VM
• 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
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2023
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/02/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/18/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/08/2016
• 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