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 Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Device was received and evaluated.The device evaluation visual inspection found a long crack on the front panel close to the insufflation connector.The unit was powered on and off and no issues were observed.Further inspection determined 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.In addition, the gas hose was found very difficult to screw to the k-connector unit due to the damages found on the k-connector threads.The device was placed for repair.If additional information becomes available this report will be supplemented accordingly.

Event Description

It was reported that the device was found with unknown fluid leaks, flows through all internal hoses.There was no patient involvement reported on this event.No user injury reported.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer final investigation.As stated previously the reported event was confirmed during the evaluation step of the complaint process in addition, an investigation was performed by the legal manufacturer based off of the information provided.A review of the instruction for use (ifu) was performed and it was confirmed that it gives instruction for proper use of the product.This may have prevented the discrepancies identified.Specifically the ifu states; handling and general precautions when using with the relief mode turned on (active), be sure to use the filter to prevent foreign objects from patients from infiltrating the device.Be sure to use the following filters.Chapter 3 installing and connecting equipment 3.3 connecting co2 bomb 1.Confirm that the high-pressure hose (maj-1080, mh-455, maj-1985) is free of scratches, cracks, and other abnormalities.Then, tighten the high-pressure hose securely to co2 feed cap on the rear panel using the supplied wrench (with a force of about 24 5n¦m (2.5kgf/m (reference)) (see fig.3.3).A review of the dhr was performed and there were no issues found within the record associated to the reported event.A root cause could not be definitively identified.Based on the results of the investigation and additional information that was provided, the following is the most likely cause to the reported complaint.For the unknown fluid leaked into the hose inside device, the most likely cause was a backflow from the connecting tube.In addition the reason for the backflow was due to handling issue.For the connector broken and high-pressure hose connection being defective.The most likely cause was due to the following factors.· it was deformed by tightening with an excessive force that was more than directed for tightening a high- pressure hose.· it was deformed by external impact.

• 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: 11037360
• MDR Text Key: 222409704
• Report Number: 8010047-2020-10666
• 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: 01/20/2021
• Supplement Dates FDA Received: 01/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1