MAUDE Adverse Event Report: CONMED UTICA THERMOGARD: DUAL FOIL, ADULT; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	51-7310
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	05/06/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The reported device is being returned to conmed for evaluation.A supplemental and final report will be filed following the completion of the device evaluation and complaint investigation.This issue will continue to be monitored through the complaint system to assure patient safety.Device not yet received.
Event or Problem Description
The customer reported that the device, 51-7310, thermogard: dual foil, adult, was being used for a left cubital tunnel release procedure on (b)(6) 2022 when it was reported ¿the pad was placed on the patients left hip.The procedure went fine, when the pad was removed there was a burn noticed where the wire is connected to the pad.Upon viewing the pad for inspection, the wires were disconnected.¿ there was no report of hospitalization for the patient.Further assessment questioning found that there was no preparation of the patient¿s skin prior to the pad application.The report stated they were unable to determine the degree of burn due to the eschar on the top layer.When asked if the device wires were attached prior to placement the reporter stated that there was ¿nothing seen out of the norm¿ with the device.The patient was treated with ointment and a bandage, then discharged with follow up with physician.This report is being raised on the basis of injury due to the unknown degree of burn.
Additional Manufacturer Narrative
Received one opened and (b)(4) closed packages of 51-7310.Lot number was verified.Performed a visual inspection, the cord set was detached from the ground pad within the opened package.There was evidence of burns on each distal end of the cord connections as well as hair.The shell connector top and bottom were also missing.Discoloration in the cured gel within the closed packages confirmed.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.A two-year review of complaint history revealed there has been a total of two complaints, regarding two devices, for this device family and failure mode.During this same time frame (b)(4) devices have been manufactured and shipped worldwide.Should all the complaint devices have been found confirmed for this reported failure, the rate of failure would be (b)(4).Per the instructions for use, the user is advised to 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 application site, clean and disinfect area to remove oils, lotions, etc., and allow to dry thoroughly.This issue will continue to be monitored through the complaint system to assure patient safety.
Event or Problem Description
The customer reported that the device, 51-7310, thermogard: dual foil, adult, was being used for a left cubital tunnel release procedure on 6may22 when it was reported ¿the pad was placed on the patients left hip.The procedure went fine, when the pad was removed there was a burn noticed where the wire is connected to the pad.Upon viewing the pad for inspection, the wires were disconnected.¿.There was no report of hospitalization for the patient.Further assessment questioning found that there was no preparation of the patient¿s skin prior to the pad application.The report stated they were unable to determine the degree of burn due to the eschar on the top layer.When asked if the device wires were attached prior to placement the reporter stated that there was ¿nothing seen out of the norm¿ with the device.The patient was treated with ointment and a bandage, then discharged with follow up with physician.This report is being raised on the basis of injury due to the unknown unknown degree of burn.

• Brand Name: THERMOGARD: DUAL FOIL, ADULT
• Common Device Name: 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: john berga ; 11311 concept blvd; largo, FL 33773 ; 7273995358
• MDR Report Key: 14563204
• Report Number: 1320894-2022-00118
• Device Sequence Number: 14896492
• Product Code: GEI
• UDI-Device Identifier: 10653405007449
• UDI-Public: (01)10653405007449(17)240301(10)202203021
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K140658
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 06/15/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 03/01/2024
• Device Model Number: 51-7310
• Device Catalogue Number: 51-7310
• Device Lot Number: 202203021
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/18/2022
• Supplement Date Received by Manufacturer: 06/08/2022
• Initial Report FDA Received Date: 06/01/2022
• Supplement Report FDA Received Date: 06/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/02/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic