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

Model Number UHI-4

Device Problem Activation Problem (4042)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

No device returned to olympus for evaluation.The cause of the user's report cannot be conclusively determined at this time.If additional information becomes available at a later time, this report will be updated accordingly.

Event Description

The user facility reported that during an unspecified procedure, the buttons on the insufflator was unresponsive.The user tried to flip the switches but the device did not activate the suction portion of the unit, as the valve is not opening to start the unit.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation and additional information collected.The following sections were updated: a1, a3, d4, d5, e2, e3, e4, g4, g7, h2, h3, h4, h6 and h10.The aware date for the initial mdr (8010047-2020-02037) is correctly march 10, 2020.The device has not been returned to olympus for evaluation.The customer reported the unit was operating correctly.Based on the investigation, this reportable event occurred because the gas-valve was not open.This event is considered to be caused by user handling rather than equipment malfunction.A review of the device history record found no deviations that could have caused or contributed to the reported issue.

• 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: 9935976
• MDR Text Key: 208769225
• Report Number: 8010047-2020-02037
• 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: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 12/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2020
• 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
• Date Manufacturer Received: 11/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1