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

Lot Number 11727

Device Problems Fluid/Blood Leak (1250); Inflation Problem (1310); Device Sensing Problem (2917)

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

Event Date 12/08/2016

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 repackager/relabeler 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

During a surgical procedure the insufflator stopped inflating every few minutes and the surgeon was having issues with controlling bleeding.It was determined that the issue was with the shuttle valve.There was a minor leak which was causing the monitor not to be able to gauge the gas levels, and due to that, the monitor would shut off due to thinking there was no gas.The issue has now been resolved and everything is functioning properly.This product problem has no impact on the patient.

• 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 V5A4W 2; CA V5A4W2
• Manufacturer Contact: jen pendlebury ; 5090 explorer drive, suite 202; mississauga, ontario L4W4T-9 ; CA L4W4T9 ; 6293822
• MDR Report Key: 6198989
• MDR Text Key: 63610648
• Report Number: 3012345110-2016-00002
• 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: 12/21/2016

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: 11727
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/22/2016
• Was Device Evaluated by Manufacturer?: Yes
• 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