MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. HIGH FLOW INSUFFLATION UNIT; INSUFFLATOR, LAPAROSCOPIC

Model Number UHI-3

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Bradycardia (1751); Low Blood Pressure/ Hypotension (1914); Loss Of Pulse (2562)

Event Date 02/11/2019

Event Type  Injury  

Event Description

Patient undergoing right robotic- assisted laparoscopic nephroureterectomy.The veress needle was used to gain intraperitoneal entry.There was no blood visualized or enteric contents with aspiration.Insufflation started and the patient became bradycardic and hypotensive leading to pulseless electrical activity (pea) arrest.Patient resuscitated and intraop echo showed gas in the right heart.Patient went to intensive care unit (icu) and had a cardiac catheterization.

• Brand Name: HIGH FLOW INSUFFLATION UNIT
• Type of Device: INSUFFLATOR, LAPAROSCOPIC
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 3500 corporate parkway; p.o. box 610; center valley PA 18034 0610
• MDR Report Key: 8435705
• MDR Text Key: 139304940
• Report Number: 8435705
• Device Sequence Number: 1
• Product Code: HIF
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/27/2019,02/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UHI-3
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/27/2019
• Event Location: Hospital
• Date Report to Manufacturer: 03/20/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/20/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 28470 DA
• Patient Weight: 98