MAUDE Adverse Event Report: NORTHGATE TECHNOLOGIES INC. CONMED; IN-LINE WARMER (INSUFFLATOR ACCESSORY)

Model Number GS1012

Device Problem Thermal Decomposition of Device (1071)

Patient Problem Partial thickness (Second Degree) Burn (2694)

Event Date 07/25/2018

Event Type  malfunction  

Manufacturer Narrative

The warmer, customer part number gs1012, nti part number 72-00181-0; serial (b)(4) arrived at nti on 8/21/2018 from customer conmed.It was confirmed that the outside sheath of the warmer was melted to the heating element.The thermistor, rtd1 (resistor which gives an indication of the temperature) measured open (infinite resistance) by use of a dmm.An open resistance on the thermistor disables the warmer circuit on the insufflator unit from functioning - this was confirmed on the customer unit, sn (b)(4).No further evaluation of the warmer could be conducted due to the open thermistor, rtd1.It is unknown how many autoclave cycles the warmer underwent prior to malfunction.A dhr review was conducted for the warmer under (b)(4).Warmer sn (b)(4) was manufactured under manufacturing order (b)(4).The unit passed final inspection after a 6-hour "burn-in" on 7/6/2017.No deviations were noted in the manufacturing of sn (b)(4).The thermistor, rtd1 measured 108.63 ohms.The insufflator unit, customer part number gs2000, nti part number 72-00258-0; serial (b)(4) also arrived at nti on 8/21/2018 from customer conmed.Initial evaluation did not identify any issue with the insufflator.The warmer, sn (b)(4) was connected to the unit, and caused an alert as the insufflator unit could not read the thermistor (operated as intended).A new warmer was connected to the unit, and the unit operated as intended - holding the temperature between 93 and 104 degrees, according to the final qc gs2000 procedure, t3-67128, section 9.A device history record review was conducted for the insufflator unit insufflator serial (b)(4) was manufactured under nti manufacturing order (b)(4).The unit was reworked in-process for "leaked at bulkhead to regulator" on 7/21/2018 where the regulator and bulkhead connector were replaced.The unit underwent "burn-in" testing for 7-hours and 30 minutes - 4 hours on 7/22, and 3 hours, 30-minutes on 7/24 - and passed final inspection including the ability of the warmer circuit to hold the temperature of co2 gas between 93 and 104 degrees fahrenheit (final qc gs2000 conmed procedure, t3-67128, section 9) on 7/24/2018.No deviations were noted that would lead to the stated complaint.Further evaluation of the unit will be conducted under nti capa (b)(4).Any additional findings will be updated via a follow-up report.

Event Description

On (b)(6) 2018, northgate technologies was made aware of an event that occured with a gs1012 gas warmer in which it was stated, "the gs1012 gas warmer, attach to the gs2000, start smelling and smoking at the heating part.The part lying on the patient belly become so hot that it burn the patient at 2nd degree on a dimension of 2 cm x 2 cm.The gs1012 was remove and the heating coil is melted to the distal part." the warmer and insufflator unit was requested under (b)(4) respectively, and the incident was documented under nti (b)(4).

Manufacturer Narrative

The system underwent evaluation by engineering under capa (b)(4).On the warmer connector, pin 4 and pin 5 are connected to the heating element.Pin 6 is connected to one side of the resistive thermal device (rtd).On the warmer board, pin 5 is connected to 24v to power the heating element and pin 4 is the return for the heating element through the field effect transistor (fet) switches to ground while pin 6 is connected directly to ground (return for the rtd).The current through the heating element is controlled by turning the fet switches on and off.If the warmer connector is rotated in such a way that it causes a one pin offset to the warmer board, the heating element would be connected directly between 24v and ground and cause overheating with no control possible form the warmer board.Misalignment of the connector could be caused by the connector components (especially the back nut) coming loose or someone dissembling and re-assembling it without paying attention to the keying of the internal parts.A similar warmer was received from the same customer with the connector disassembled.The root cause was determined to be the misalignment (axial misalignment) of the warmer connector to the warmer port on the device resulting from lose or incorrect assembly of the connector post manufacturing.As a result, unrestricted current flow (> 1.2a) caused the heater element to heat up to 350+ deg f; subsequently melting the plastic sheath and generating smoke.This was further verified by actually attaching an improperly assembled warmer (the pins were rotated to create a one pin axial offset) to a warmer board.The result was that the warmer sheath heated up to 305 deg f with smoke coming out from the warmer inlet within 3 minutes.This was further confirmed via photographic evidence of a similar warmert, in that the connector arrived at nti disassembled (photo).This warmer received at nti on 7/30/2018 was properly assembled, however the back nut on the connector was able to be removed by hand (where it is normally only able to be removed by the use of a tool).

• Brand Name: CONMED
• Type of Device: IN-LINE WARMER (INSUFFLATOR ACCESSORY)
• Manufacturer (Section D): NORTHGATE TECHNOLOGIES INC.; 1591 scottsdale court; elgin IL 60123
• MDR Report Key: 7831440
• MDR Text Key: 118712856
• Report Number: 0001450997-2018-00002
• Device Sequence Number: 1
• Product Code: HIF
• UDI-Device Identifier: 10845854045220
• UDI-Public: 10845854045220
• Combination Product (y/n): N
• PMA/PMN Number: K120151
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 08/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/29/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: GS1012
• Device Catalogue Number: GS1012
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/21/2018
• Date Manufacturer Received: 07/30/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention