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

Model Number UHI-3

Device Problem Fluid/Blood Leak (1250)

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

Event Type  malfunction  

Manufacturer Narrative

The device has not been returned for evaluation.If additional information becomes prior to the conclusion of the investigation, a supplemental report will be filed.Investigation activities have been opened to manage the actions related to this issue and any required mdr reporting.

Event Description

It was reported, the high flow insufflation unit had an unknown liquid inside of the system tubes.According to the initial reporter, the procedure was completed using the same device and no replacements were required.There was no patient harm or consequence reported as a result of this event.

Manufacturer Narrative

Corrected information: e3 & g2 - initial reporter's occupation is manager of specialized center service and maintenance.This supplemental report is being submitted to provide the results of the manufacturer¿s investigation.A device evaluation, a review of the device history record (dhr), a review of the instructions for use (ifu), as well as a historical trending analysis were conducted during this investigation.The device in question was returned and the user¿s report was confirmed.The unit had unknown liquid inside of the pneumatic system tubes.In addition to the fluid, rust was noted on the real panel, and bottom chassis.Additional wear was discovered in the form of scratches on the top cover and front panel.The review of the dhr did not find any abnormalities or anomalies identified during production.The device met all specifications upon release.The ifu contains the following statements: ¿when relief mode is set to on, the intra-cavity gas will flow backward into the equipment for relief through the built-in valve.To prevent the internal surfaces of the equipment from being contaminated, be sure to use a disposable filter.When no filter is used, make sure relief mode is set to off.¿ while a definitive root cause could not be determined, based on the results of the investigation, it is believed that one of the following caused the reported event: liquid flowed backward from the output hose when gas pressure was not applied.Foreign object got inside from the high-pressure hose side.Gas flowed backward because the filter was not properly attached when relief mode was set ¿on¿.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: 12124904
• MDR Text Key: 280568137
• Report Number: 8010047-2021-08491
• Device Sequence Number: 1
• Product Code: HIF
• Combination Product (y/n): N
• PMA/PMN Number: K014166
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 08/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/06/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UHI-3
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1