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

Model Number UHI-4

Device Problem No Flow (2991)

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

Event Date 02/09/2023

Event Type  malfunction  

Manufacturer Narrative

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 that during preventative maintenance, the insufflation of the high flow insufflation unit was not correct and a leak was detected when opening the device.There was no reported patient harm or impact due to this event.

Manufacturer Narrative

This report is being supplemented to provide results of device evaluation.The device was returned and evaluated by olympus.Evaluation found the complaint was confirmed.A visual inspection was done on the as is received condition of the device.The top cover had several minor scratches, the insufflation connector and the pinch valve on the front panel had no indications of physical damage, the co2 gas inlet on the rear panel had minor signs of residue on the threads of the inlet, the link-in, link-out, and foot switch connectors had no signs of damage, and the rear panel was dented in and deformed on the power inlet side.The screws from the top cover and the top cover were then removed.Corrosion was noted on the chassis.Also, the s-shaped pipe was detached from the k-connector unit and the primary pressure reducer.The s-shaped pipe was placed back onto the k-connector unit along with the primary pressure reducer and tightened.A co2 tank and a test high pressure hose was attached to the gas inlet and the co2 gas tank was opened.A power cord was connected and the device was powered on by pressing the power switch on the front panel.The device powered on and the flow rate mode option was pressed on the front panel until "high" was selected.The insufflation start button was pressed on the front panel and the "+" button was pressed several times to open the electromagnetic valve to feed air; however, no air was felt flowing through the insufflation connector on the front panel.Further troubleshooting was done and a test primary pressure reducer was used in the device.The s-shaped pipe was placed onto the k-connector unit and the test primary pressure reducer.Air was able to flow through the insufflation connector on the front panel and no leaks were identified on the s-shaped pipe when testing it.The device was further inspected and the piping tube inside device is damaged and gas leak occurs, there was no air flow due to faulty gas regulator, a faulty main board caused an error e03, and the chassis was corroded.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 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, the definitive root cause of the air supply issue, damaged plumbing tube, and error e03 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: 16543998
• MDR Text Key: 311420661
• Report Number: 3002808148-2023-02500
• 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
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup,Followup
• Report Date: 05/22/2023

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
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/25/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/06/2019
• 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