MAUDE Adverse Event Report: NORTHGATE TECHNOLOGIES INC. GAS WARMER IN-LINE TUBING; INSUFFLATOR TUBING

Catalog Number GS1012

Device Problem Excessive Heating (4030)

Patient Problems Burn(s) (1757); Partial thickness (Second Degree) Burn (2694)

Event Date 07/23/2018

Event Type  Injury  

Manufacturer Narrative

This report is being filed as a voluntary distributor report.The manufacturer northgate technologies is responsible for performing evaluation, investigation and any remedial actions related to this reported device issue per agreement with conmed corporation.

Event Description

This is a voluntary distributor report.The conmed representative reported that during use of the gs1012 gas warmer in-line in a surgical procedure the gs1012 gas warmer, attach to the gs2000, started to smelling and smoke at the heating part.The part lying on the patient's belly became so hot that it burn the patient at 2nd degree on a dimension of 2 cm x 2 cm.The gs1012 was removed and the heating coil is melted to the distal part.No additional information regarding the patient status or procedure was provided.The oem manufacturer northgate technologies has been notified of this customer complaint report.Northgate technologies has complaint processing and regulatory reporting responsibility.This report is raised on the basis of a reported patient injury.

Event Description

This is a voluntary distributor report.

Manufacturer Narrative

Corrections: - change report type from importer to manufacturer for voluntary distributor report of us device, - section e - updated with reporter's name ,- section f made blank, - section g - updated with mdr reporter's name and original equipment manufacturer name and address; 510(k) number.Additional data: - added patient information from customer complaint form - added gs2000 insufflator as concomitant device.

• Brand Name: GAS WARMER IN-LINE TUBING
• Type of Device: INSUFFLATOR TUBING
• Manufacturer (Section D): NORTHGATE TECHNOLOGIES INC.; 1591 scottsdale court; elgin IL 60123
• MDR Report Key: 7753353
• MDR Text Key: 116147502
• Report Number: 1017294-2018-00122
• Device Sequence Number: 1
• Product Code: HIF
• Combination Product (y/n): N
• PMA/PMN Number: K022052
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 08/06/2018,08/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: GS1012
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/06/2018
• Distributor Facility Aware Date: 07/25/2018
• Event Location: Hospital
• Date Report to Manufacturer: 07/30/2018
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/06/2018
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/09/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: GS2000 50L ABDOMINAL INSUFFLATOR
• Patient Outcome(s): Other
• Patient Age: 49 YR