MAUDE Adverse Event Report: CONMED UTICA THERMOGARD PLUS ABC DUAL DISPERSIVE ELECTRODE; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Catalog Number 7-382

Device Problems Temperature Problem (3022); Excessive Heating (4030)

Patient Problem Burn(s) (1757)

Event Date 10/14/2021

Event Type  Injury  

Event Description

The sales representative reported on behalf of the customer that the device, 7-382,thermogard plus abc dual dispersive electrode was being used on (b)(6) 2021 during a retroperitoneal lymph node dissection and open aortic repair procedure and the patient received bilateral burns; one on each buttock.One burn was at the site of the conmed abc dispersive electrode connected to the helix argon beam unit, while the second burn was at the site of a standard dispersive electrode connected to an esu from a different company (medtronic).The medtronic esu, helix argon beam unit and standard dispersive electrode will be listed as concomitant devices.The reporter also mentioned that the patient was on a warming pad (warm water running through an underbody pad) during the surgery, and that this warming pad was close to or in contact with the two dispersive electrodes/grounding pads.The reporter stated it was a long case 11.5 hours and that perhaps another site on patient should have been chosen for the two dispersive electrodes/grounding pads.The procedure was completed.Further assessment was sent; however, to date no reply has been received.This report is being raised on the basis of injury due to unknown degree of burn.

Manufacturer Narrative

The device is not expected to be returned for evaluation and review.However, the complaint investigation is not complete at this time.A supplemental and final report will be filed following the completion of the complaint investigation.This issue will continue to be monitored through the complaint system to assure patient safety.

Manufacturer Narrative

The reported event of ¿bilateral burns to the buttocks¿ is inconclusive.The device will not be returned for evaluation and no photographic evidence was provided; therefore, root cause cannot be identified.The manufacturing documents from the device history record have been reviewed with special attention to the manufacturing and inspection of the product.The product released for distribution was found to have met all specifications prior to shipment.This is the only complaint for this lot number and failure mode within the past two years.(b)(4).Per the instructions for use, the user is advised the following: select a well vascularized site in close proximity to the surgical site (anterior arm or thigh is recommended).Avoid placement on bony prominence, skin lesions or folds, tattoos, scars, metal prosthesis or near ecg electrodes and cables.Do not apply where fluid may pool.Prepare the skin at the application site according to facility protocol.If no protocol exists, clip excess hair at the application site, clean and disinfect area to remove oils, lotions, etc.And allow to dry thoroughly.Inspect the pad and cable.Check expiration date on package.After patient is in the final position, carefully remove the pad from the disposable liner by grasping the liner from the end located away from the cable attachment end of the pad and slowly peeling the pad from the disposable liner.Avoid excess skin or finger contact with the adhesive or gel surface prior to application.This issue will continue to be monitored through the complaint system to assure patient safety.

Event Description

Update: further assessment found that there was no delay to the procedure.The burn was mild to moderate and the patient is ok.The sales representative reported on behalf of the customer that the device, 7-382,thermogard plus abc dual dispersive electrode was being used on (b)(6) 2021 during a retroperitoneal lymph node dissection and open aortic repair procedure and the patient received bilateral burns; one on each buttock.One burn was at the site of the conmed abc dispersive electrode connected to the helix argon beam unit, while the second burn was at the site of a standard dispersive electrode connected to an esu from a different company (medtronic).The medtronic esu, helix argon beam unit and standard dispersive electrode will be listed as concomitant devices.The reporter also mentioned that the patient was on a warming pad (warm water running through an underbody pad) during the surgery, and that this warming pad was close to or in contact with the two dispersive electrodes/grounding pads.The reporter stated it was a long case 11.5 hours and that perhaps another site on patient should have been chosen for the two dispersive electrodes/grounding pads.The procedure was completed.Further assessment was sent; however, to date no reply has been received.This report is being raised on the basis of injury due to unknown degree of burn.

• Brand Name: THERMOGARD PLUS ABC DUAL DISPERSIVE ELECTRODE
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): CONMED UTICA; 525 french rd; utica NY 13502
• Manufacturer (Section G): CONMED UTICA; 525 french rd; utica NY 13502
• Manufacturer Contact: robin drum ; 11311 concept blvd; largo, FL 33773 ; 8653881978
• MDR Report Key: 13092773
• MDR Text Key: 282812470
• Report Number: 1320894-2021-00459
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K140658
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/02/2022

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 Expiration Date: 08/04/2023
• Device Catalogue Number: 7-382
• Device Lot Number: 202108041
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/03/2021
• Initial Date FDA Received: 12/28/2021
• Supplement Dates Manufacturer Received: 01/25/2022
• Supplement Dates FDA Received: 02/02/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/04/2021
• Is the Device Single Use?: No
• Patient Sequence Number: 1
• Treatment: HELIX ARGON BEAM UNIT; HELIX ARGON BEAM UNIT; MEDTRONIC ESU; MEDTRONIC ESU; STANDARD DISPERSIVE ELECTRODE; STANDARD DISPERSIVE ELECTRODE; WARMING PAD; WARMING PAD
• Patient Outcome(s): Other
• Patient Age: 35 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic