MAUDE Adverse Event Report: NORTHGATE TECHNOLOGIES INC. INSUFFLATOR 40L WARM/RDY/VIDEO/CPS/RMT; INSUFFLATOR, LAPAROSCOPIC

Catalog Number GS1002

Device Problem Device Inoperable (1663)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/14/2017

Event Type  malfunction  

Manufacturer Narrative

The product has not yet been returned for evaluation.When the device is returned, an evaluation will be performed and upon completion a supplemental medwatch report will be submitted.

Event Description

The customer reported that during a laparoscopic colectomy procedure while the insufflator 40l warm/rdy/video/cps/rmt was operating, the surgeon started cutting the colon.After the insufflator worked for about 10 minutes, the insufflator powered off.The surgeon removed the instrument from the patient's body before the air pressure was gone.There was a 10-minute delay while another insufflation device was obtained and set-up to complete the procedure.This procedure was completed successfully with no patient harm.This report if being filed for a reported malfunction with potential for serious injury.

Manufacturer Narrative

Conmed evaluated the returned used insufflator.Visual inspection found no noted physical problems with this device.Thorough testing per procedure found this device meets all specifications.The customer complaint that the device powers off during operation was unable to be duplicated.This unit was returned to the oem manufacturer for further analysis.The device was functionally tested and the reported issue could not be verified.Based on the service history record there was not a positive history of client compliance with the recommended 12 month preventative maintenance schedule.A review of complaint history for the previous two years shows this is the second complaint for a gs1002 insufflator that was reported to shut off during use.During this same two year period there have been no reports of patient adverse effects related to the use of this device.The gs1000 series of insufflators are used for gas distension of the abdomen for diagnostic and/or operative laparoscopy.They should be used only when laparoscopic procedures are called for, and should therefore not be used for any other treatments.They are designed to function with specific laparoscopic instruments that provide passage of gas to the intra-abdominal cavity and should only be used with instruments specifically designed for that purpose.They should only be used under the direct guidance of a skilled laparoscopic surgeon.

• Brand Name: INSUFFLATOR 40L WARM/RDY/VIDEO/CPS/RMT
• Type of Device: INSUFFLATOR, LAPAROSCOPIC
• Manufacturer (Section D): NORTHGATE TECHNOLOGIES INC.; 1591 scottsdale court; elgin IL 60123
• Manufacturer (Section G): NORTHGATE TECHNOLOGIES INC.; 1591 scottsdale court; elgin IL 60123
• Manufacturer Contact: denise curtis ; 11311 concept boulevard; largo, FL 33773 ; 7273995515
• MDR Report Key: 6549352
• MDR Text Key: 74593181
• Report Number: 1017294-2017-00052
• Device Sequence Number: 1
• Product Code: HIF
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: K022052
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/27/2017

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 Catalogue Number: GS1002
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/16/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/19/2017
• Initial Date FDA Received: 05/05/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/27/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/20/2010
• 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
• Patient Age: 57 YR