MAUDE Adverse Event Report: CONMED ThermoGard; electrosurgical, cutting & coagulation & accessories

Catalog Number	CRA-SGP
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Burn(s) (1757)
Type of Reportable Event	Serious Injury
Event or Problem Description
The customer reported that a cra-sgp, thermogard dual dispersive electrode,contact quality monitor, device was used during a cervical coolief procedure on an unknown date when it was reported, ¿patient sustained a burn beneath the grounding pad.They state the grounding pad started on the left lateral thigh of the patient, but they noticed that the grounding pad slid out of position, so they removed it and wiped the skin dry then placed in the original position.Once the procedure was finished, they noticed slight redness/warmth on the skin where the grounding pad was placed.She reports that they checked the skin again after they removed him from the room and noticed that there was some peeling up of the skin with discoloration where the pad was placed.¿ the patient is reported as ¿ok." when asked if there was medical intervention the reporter stated, ¿treated and dressed." there was no report of hospitalization for the patient.This report is being raised due to the reported injury of unknown degree of burn.
Additional Manufacturer Narrative
G3 initial awareness date was (b)(6) 2026.The reported device has been returned to conmed; however, the complaint investigation has not been completed.A supplemental and final report will be filed following the completion of the complaint investigation.We will continue to monitor per regulatory requirements to help ensure patient safety.

• Brand Name: ThermoGard
• Common Device Name: electrosurgical, cutting & coagulation & accessories
• Manufacturer (Section D): CONMED; 525 french rd; utica NY 13502
• Manufacturer (Section G): CONMED Utica; 525 french rd; utica NY 13502
• Manufacturer Contact: john berga ; 525 french rd.; utica, NY 13502 ; +1(727)399-5358
• MDR Report Key: 50320224
• Report Number: 1320894-2026-00205
• Device Sequence Number: 15964697
• Product Code: GEI
• UDI-Device Identifier: 20653405986581
• Combination Product (Y/N): N
• Initial Reporter State: MS
• Initial Reporter Country: US
• PMA/510(K) Number: K140658
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Type of Report: Initial,Followup
• Report Date (Section B): 09/17/2026

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
• Operator of Device: Health Professional
• Device Catalogue Number: CRA-SGP
• Device Lot Number: 202506241
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/03/2026
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 08/20/2026
• Initial Report FDA Received Date: 08/19/2026
• Supplement Report FDA Received Date: 09/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/24/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Patient Sequence Number: 1
• Patient Age: 71 YR
• Patient Sex: Male
• Patient Weight: 269 LB