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

Model Number UHI-4

Device Problems Defective Device (2588); Device Sensing Problem (2917)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/27/2020

Event Type  malfunction  

Manufacturer Narrative

The device has not returned to olympus medical systems corp.(omsc) for evaluation.There were no further details provided.If significant additional information is received, this report will be supplemented.

Event Description

Olympus medical systems corp.(omsc) was informed that cylinder pressure indicator failure of the front panel of the device occurred.Other detailed information was not provided.There was no report of patient injury associated with the event.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer¿s final investigation.The device was returned to an olympus service center for evaluation and it was confirmed that the pressure indicator was defective.This was attributed to normal wear due to the age of the device.Based on the legal manufacturer¿s investigation, the device history record (dhr) was reviewed and there were no problems found during the manufacturing of the device.The device met all specifications at the time of shipment.

• 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: 10584622
• MDR Text Key: 209022996
• Report Number: 8010047-2020-06845
• 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: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 01/18/2021

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: No Information
• Device Model Number: UHI-4
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/27/2020
• Initial Date FDA Received: 09/24/2020
• Supplement Dates Manufacturer Received: 01/07/2021
• Supplement Dates FDA Received: 01/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1