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

Model Number UHI-4

Device Problem No Flow (2991)

Patient Problem No Patient Involvement (2645)

Event Date 12/08/2020

Event Type  malfunction  

Manufacturer Narrative

As part of our investigation, the technical assistance center (tac) assisted the onsite support specialist with troubleshooting.The tubing was placed in a canister and worked; however, the pressure was low at 20.Tac requested that the unit¿s mode be verified and provide the flow rate setting.The onsite support specialist reported that the unit was set to low flow mode.Tac reported that before an answer was received on the cavity mode the issue resolved.The unit was not returned to the service center for evaluation.The cause of the reported event cannot be determined at this time.

Event Description

An onsite support specialist reported that the customer¿s high flow insufflation unit was not insufflating.The onsite support specialist replaced two foot pedals there were no alarms or error codes noted.There was no patient involvement.

Manufacturer Narrative

This supplemental report is being submitted to provide the legal manufacturer investigation and additional information from the customer.The legal manufacturer (lm) reviewed the content of this complaint for further investigation.The legal manufacturer was unable to determine the root cause.As the results of the dhr review, it was confirmed that there was no abnormality in manufacturing, concession, and variation.It was confirmed that there was no unevenness.The lm reported that the most probable cause for the reported event is as follows: it was assumed that the problem occurred due to setting-related problems because the problem has been solved after checking the setting values.No alarm and error code occurred.It was confirmed that the problem was solved before confirming the mode and flow rate settings and setting them to the constant flow mode and receiving the response of the cavity mode.

• 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: 11118707
• MDR Text Key: 225185366
• Report Number: 8010047-2021-00884
• 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,health
• Type of Report: Initial,Followup
• Report Date: 03/04/2021

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?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/08/2020
• Initial Date FDA Received: 01/05/2021
• Supplement Dates Manufacturer Received: 02/04/2021
• Supplement Dates FDA Received: 03/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1