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

Model Number UHI-4

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Device was received and evaluated.The device evaluation visual inspection found no abnormalities on the appearance of the unit.There was no issue found when it was powered on and off.Further inspection however, found an unknown fluid on both the a tube and b tube part of the device.In addition, visual inspection determined that the a tube and c tube part of the device were both observed to be not in clear color, a brownish color was noted.The unknown fluid invaded inside the tubes, manifold unit, electropnumatic proportional valve and the 1st regular unit of the device causing failure to the flow rate measurement accuracy check.The device was placed for repair.If additional information becomes available this report will be supplemented accordingly.

Event Description

It was reported that during an unspecified procedure the device was found with unknown fluid leaks, flows through all internal hoses.There were no further details provided regarding the event.There was no patient harm or injury reported on this event.No user injury reported.

Manufacturer Narrative

This supplemental report is being submitted to provide review of the device history records (dhr) and investigation conclusion.The device history records for this device were reviewed and all records indicated that the product was manufactured according to all applicable procedures and met final product release criteria.No abnormalities were found.The root cause of the reported issue was not identified.It is assumed that the event occurred due to a backward flow into the inside.It was presumed that the cause of the countercurrent was due to negative pressure due to the influence of the environment and connection conditions, and no or inadequate application of the filter.As stated on the ifu (instruction for use) the user manual states: when relief mode is set to on, cavity gas and/or body fluids (e.G., blood) can flow backward into and potentially contaminate the equipment.To prevent this, olympus strongly recommends the use of a disposable filter in the co2 supply line between the uhi-4 and the patient.Olympus recommends filter type pall or01h (0.2m, hydrophobic) or equivalent filters; contact olympus for further details.Olympus will continue to monitor complaints for 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: 11037665
• MDR Text Key: 222409647
• Report Number: 8010047-2020-10667
• Device Sequence Number: 1
• Product Code: HIF
• UDI-Device Identifier: 04953170324147
• UDI-Public: 04953170324147
• 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,user f
• Type of Report: Initial,Followup
• Report Date: 01/28/2021

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: 11/06/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/24/2020
• Initial Date FDA Received: 12/18/2020
• Supplement Dates Manufacturer Received: 01/11/2021
• Supplement Dates FDA Received: 01/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1