MAUDE Adverse Event Report: CONSOLIDATED MEDICAL EQUIPMENT COMPANY CONMED; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Catalog Number	130317
Medical Device Problem Codes	Therapy Delivered to Incorrect Body Area (1508); Electrical Shorting (2926)
Health Effect - Clinical Code	Full thickness (Third Degree) Burn (2696)
Date of Event	06/02/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Although we don¿t have evidence of the patient burn, we can confirm that a device malfunctioned based on photographic evidence.The device appears to have sent an electrical current through the side of the handpiece and burned a hole through the plastic casing.Root cause cannot be determined, however, based upon the ifu; a possible cause of this event could high power setting and long activation time.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.A two-year lot history review shows a total of one (1) device for this lot number and failure mode.A two-year review of complaint history revealed there has been a total of five reports, regarding eight 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 use lowest possible power setting on the associated electrosurgical unit capable of achieving desired surgical effect.Activation time should be as short as possible.We will continue to monitor per regulatory requirements to help ensure patient safety.
Event or Problem Description
A customer reported that the 130317, electrosurgical pencil, reusable device was used in a tonsillectomy procedure on (b)(6)2025, and ¿the item burned the pt.The procedure was completed with another pen.¿.Per further assessment, the device "appears to have sent an electrical current through the side of the handpiece near the bottom.¿.The surgeon indicated the injury ¿appears to be third degree" burn.¿the surgical intervention that was required was a repair to the commissure and inside the patient's mouth.It took about 30 minutes for the doctor to repair.Since the burn, the patient has had one additional surgery on the commissure with a microflap closure to help prevent any lasting damage to their smile.That was also done as an outpatient procedure, and the patient is home recovering and being followed by the surgeon.¿.The surgery was completed with the use of an esu-valleylab force fx device and a delay of 30 minutes.Notice was received on 23jun2ddddd 2023 that the customer has reported this incident under medwatch report no.Mw5171323.A search of the complaint system has not found a complaint reported for this device/lot number during this timeframe.This report is being raised due to the reported injury of a third-degree burn to the patient.

• Brand Name: CONMED
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): CONSOLIDATED MEDICAL EQUIPMENT COMPANY; ave. alejandro dumas 11321; complejo industrial chihuahua; chihuahua 31136 ; MX 31136
• Manufacturer (Section G): CONSOLIDATED MEDICAL EQUIPMENT COMPANY; ave. alejandro dumas 11321; complejo industrial chihuahua; chihuahua 31136 ; MX 31136
• Manufacturer Contact: beth madeline ; 11311 concept blvd; largo, FL 33773 ; 7274708358
• MDR Report Key: 22357069
• Report Number: 3007305485-2025-00105
• Device Sequence Number: 15453044
• Product Code: GEI
• UDI-Device Identifier: 10653405002208
• UDI-Public: (01)10653405002208(17)300109(10)202501104
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K791137
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/30/2025

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 130317
• Device Lot Number: 202501104
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/02/2025
• Initial Report FDA Received Date: 06/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/10/2025
• Is the Device Labeled for Single Use? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ESU-VALLEYLAB FORCE FX, SN: (B)(6)
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 13 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic