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

Model Number UHI-3

Device Problems Electrical /Electronic Property Problem (1198); No Flow (2991)

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

Event Type  malfunction  

Manufacturer Narrative

The suspect device was evaluated and repaired by olympus.The reported insufflation problem was confirmed; the front panel of the insufflation unit was found broken at the insufflation port.When the unit was powered, the 2 green leds of the bar graph pressure indicator lit up, despite no co2 gas inside the unit.The cause of the problem was isolated to a faulty main board.

Event Description

A user facility returned the olympus, uhi-3, high flow insufflation unit for repair for a reported problem with the insufflation port.Upon evaluation of the returned device, it was noted that no co2 gas was supplied and the 2 green led's were lit.There was no patient injury or harm, associated with the problem, reported to olympus.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's investigation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Based on the results of the legal manufacturer's investigation, the phenomenon occurred because the main circuit board failed.It is likely this failed due to normal aging / deterioration since more than 13 years have passed since the subject device was manufactured.

• 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: 11396680
• MDR Text Key: 234220974
• Report Number: 8010047-2021-03160
• 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: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 03/18/2021

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-3
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/29/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/03/2021
• Initial Date FDA Received: 03/01/2021
• Supplement Dates Manufacturer Received: 03/18/2021
• Supplement Dates FDA Received: 03/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1