MAUDE Adverse Event Report: NORTHGATE TECHNOLOGIES INC. NOVADAQ 50L INSUFFLATOR

Lot Number 89607DYA

Device Problems Excess Flow or Over-Infusion (1311); Increase in Pressure (1491)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/01/2016

Event Type  malfunction  

Manufacturer Narrative

Northgate technologies inc.Is the original equipment manufacturer (oem) of the 50l insufflator, which is the subject of this reportable event.Novadaq technologies inc.Is the re-packager/re-labeler of this 50l insufflator.Novadaq's name and branding is present on the insufflator's packaging and labeling; that is, the device is labeled as the "novadaq 50l insufflator".Since this device malfunction/product problem occurred with the novadaq-branded insufflator, novadaq technologies inc.Is therefore the party submitting this report.

Event Description

A 50l insufflator (manufactured by northgate technologies) was being used with novadaq tubing and novadaq pinpoint system for an entire rt hemicolectomy case.The monitor was set at high flow: 25 and pressure: 15.About an hour and a half into the case, the patient's abdomen became over-inflated.The actual pressure on the insufflator monitor read 35 and was rising up to 40.The patient's co2 level was rising past 60 when the physician decided to end the laparoscopic portion of the procedure early due to the insufflator not functioning properly.After the open portion of the procedure, the surgeon decided to go back in laparoscopically, despite the clinical representative's recommendation to not use the insufflator again.The surgeon used the insufflator for a total of about 5 minutes and there were no issues.

• Brand Name: NOVADAQ 50L INSUFFLATOR
• Type of Device: INSUFFLATOR
• Manufacturer (Section D): NORTHGATE TECHNOLOGIES INC.; 1591 scottsdale court; elgin IL 60123
• Manufacturer (Section G): NOVADAQ TECHNOLOGIES INC.; 8329 eastlake drive, unit 101; burnaby, british columbia V5A 4 W2; CA V5A 4W2
• Manufacturer Contact: jen pendlebury ; 8329 eastlake drive, unit 101; burnaby, british columbia V5A 4-W2 ; CA V5A 4W2 ; 6293822
• MDR Report Key: 6139831
• MDR Text Key: 61540686
• Report Number: 3012345110-2016-00001
• Device Sequence Number: 1
• Product Code: HIF
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K120151
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date: 12/01/2016

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: Physician
• Device Lot Number: 89607DYA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/14/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/01/2016
• Initial Date FDA Received: 12/01/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1