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

Model Number UHI-4

Device Problem Loss of Power (1475)

Patient Problem Low Blood Pressure/ Hypotension (1914)

Event Type  malfunction  

Manufacturer Narrative

The device referenced in this report was not returned to olympus for evaluation.The definitive cause of the user's experience cannot be determined at this time.The investigation is ongoing.This report will be updated upon completion of the investigation or upon receipt of additional relevant information.

Event Description

The customer reports during a bronchoscopy; mediastinoscopy; robotic assisted right upper lobe (rul) lobectomy procedure using a high flow insufflation unit with a davinci xi robot, a major power outage was experienced during the procedure, causing the insufflation unit to power off.The physician was displeased when the power was restored, and the settings were different than he expected.The patient did experience a drop in blood pressure, but this was corrected when the insufflator tubing was disconnected.No intervention was required as the patient stabilized after the increased chest pressure was relieved.The procedure was completed as intended once equipment was interrogated and restarted.The patient¿s current condition is discharged from facility and recovering at home with no additional consequences reported.The biomedical engineer at the facility reported both the davinci robot and insufflation device were evaluated and no problems were found with either device.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final 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 investigation, the cause of the device losing power occurred from a power outage at the facility.The investigation confirmed no device malfunction occurred.Olympus will continue to monitor field performance for 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
• Manufacturer Contact: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 12864770
• MDR Text Key: 286464593
• Report Number: 8010047-2021-14952
• Device Sequence Number: 1
• Product Code: HIF
• UDI-Device Identifier: 04953170324147
• UDI-Public: 04953170324147
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K122180
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date: 01/03/2022

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
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/01/2021
• Initial Date FDA Received: 11/23/2021
• Supplement Dates Manufacturer Received: 12/13/2021
• Supplement Dates FDA Received: 01/03/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/09/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: DAVINCI ROBOT, SN: (B)(4)
• Patient Age: 72 YR
• Patient Sex: Male
• Patient Weight: 78 KG