MAUDE Adverse Event Report: NORTHGATE TECHNOLOGIES INC INSUFFLATOR 40L WARM/RDY/VIDEO/CPS/RMT; GS1002 INSUFFLATOR

Catalog Number GS1002

Device Problem Infusion or Flow Problem (2964)

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

Event Date 10/19/2017

Event Type  malfunction  

Manufacturer Narrative

The reported device is being returned to conmed for evaluation and repair.A supplemental and final report will be filed following the completion of the device evaluation and complaint investigation.

Event Description

The user facility reported that during a procedure the gs1002 insufflator was losing pressure.To date, no additional information has been provided regarding the patient or the procedure.No patient injury was reported.  this reported is being raised based on a reported malfunction with potential for injury with recurrence.

Manufacturer Narrative

The device was returned to conmed for evaluation.The unit was ran overnight set at 20 mmhg and it did not lose any pressure.Therefore, the reported failure could not be confirmed.A service history was conducted and there was no information found related to the reported failure.A two-year review of complaint history revealed 6 similar incidents for this product family and failure mode.However, only 1 of those incidents is confirmed.The instructions for use advise the user of the following.The user should be thoroughly familiar with the operation of this device prior to use.The insufflator should be inspected upon receipt and before each use.If at any time the unit performs abnormally, remove the unit from service and have it repaired.The front panel gas supply indicator blinks and the unit tones continuously when there is an issue with the gas supply.This issue will continue to be monitored through the complaint system to assure patient safety.

• Brand Name: INSUFFLATOR 40L WARM/RDY/VIDEO/CPS/RMT
• Type of Device: GS1002 INSUFFLATOR
• Manufacturer (Section D): NORTHGATE TECHNOLOGIES INC; 1591 scottsdale ct; elgin IL 60123
• Manufacturer (Section G): CONMED CORPORATION; 525 french road; utica NY 13502 5994
• Manufacturer Contact: martha camacho urribarri ; 525 french road; utica, NY 13502 ; 3156243051
• MDR Report Key: 7053401
• MDR Text Key: 93446158
• Report Number: 1017294-2017-00125
• Device Sequence Number: 1
• Product Code: HIF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K022052
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/19/2017

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: 11/10/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/27/2017
• Initial Date FDA Received: 11/22/2017
• Supplement Dates Manufacturer Received: 12/12/2017
• Supplement Dates FDA Received: 12/19/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2009
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1