MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. HIGH FLOW INSUFFLATION UNIT

Model Number UHI-4

Device Problem Gas/Air Leak (2946)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

The device was received for evaluation.Evaluation of the device determined that the gas tubes were dirty inside.A strange liquid was found inside the gas tubes which invaded into the 1st regulator unit, electropneumatic proportional valve , main fold pipe and the k-connector unit.In addition, the front panel was found broken at the bottom side.The device was placed for repair.As stated on the ifu and as a preventive measure, the user manual states : keep fluids away from all electrical equipment.If fluids are spilled on or into the high flow insufflation unit, stop operation of the unit immediately and contact olympus.Always use the uhi-4 as outlined in this instruction manual.Improper use will not only impair functions and prevent optimum performance, but may cause equipment damage and/or complications.Before each use, always inspect the equipment as outlined in this instruction manual.

Event Description

It was reported that the uhi-4 device was found to have a leak at regulation valve.There was no patient or user harm reported due to the event.

Manufacturer Narrative

The following fields were updated: g4, g7, h2, h6, h10.This supplemental report is being submit to provide the results of the manufacturer's investigation.A review of the device history record (dhr) was conducted as part of the investigation.The review of the dhr did not find any abnormalities or anomalies identified during production.The device met specifications upon release.The root cause was not identified.Probable causes include damage from user handling.Liquid had entered the gas tube and this is assumed to be the cause of the regulator damage.Olympus will continue to monitor the field performance of this device.

• Brand Name: HIGH FLOW INSUFFLATION UNIT
• Type of Device: HIGH FLOW INSUFFLATION UNIT
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• MDR Report Key: 10034225
• MDR Text Key: 215989884
• Report Number: 8010047-2020-02547
• Device Sequence Number: 1
• Product Code: HIF
• Combination Product (y/n): N
• PMA/PMN Number: K122180
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 12/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 04/10/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/11/2020
• Initial Date FDA Received: 05/07/2020
• Supplement Dates Manufacturer Received: 12/03/2020
• Supplement Dates FDA Received: 12/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1