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

Model Number UHI-4

Device Problems Gas/Air Leak (2946); Pressure Problem (3012)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/26/2021

Event Type  malfunction  

Manufacturer Narrative

Since the subject device has been not returned to omsc for the evaluation, the exact cause of the reported event could not be conclusively determined at this time.If additional information becomes available, this report will be supplemented.

Event Description

Olympus medical systems corp.(omsc) was informed that it was found the co2 gas leakage from the subject device when the subject device was returned by the user to the spare parts center of olympus (b)(4) as one of the loaner devices.The user (borrower) reported that the co2 gas leakage had found before the user set up the subject device at the user facility and so the subject device had been returned to olympus (b)(4).At the incoming inspection, olympus (b)(4) checked the subject device and found the co2 gas leakage from the pressure reducing valve, the failure of the electropneumatic proportional valve, the failure of the manifold valve, and the aging co2 gas tubes.There was no report of patient injury associated with this event.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information.Since the subject device was not returned to olympus medical systems corp.(omsc), it could not be investigated.Omsc reviewed the manufacturing history (dhr) of the subject device and confirmed no irregularity.The exact cause of the reported event could not be conclusively determined.However, based on the report of olympus china, omsc surmised there was the possibility this phenomenon was attributed to the manifold unit failure of the subject device due to the aging deterioration by passing more than 6 years since manufacturing the subject device.If additional information becomes available, this report will be supplemented.

• 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: 11341517
• MDR Text Key: 232588035
• Report Number: 8010047-2021-02817
• 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: 03/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/18/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: UHI-4
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1