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

Catalog Number	130318A
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Superficial (First Degree) Burn (2685)
Date of Event	04/25/2025
Type of Reportable Event	Malfunction
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.We will continue to monitor per regulatory requirements to help ensure patient safety.
Event or Problem Description
A distributor reported on behalf of a customer that the 130318a, electrosurgical handpiece device was used in an unnamed procedure on (b)(6) 2025, and ¿during surgery the cautery the provider was using caused a small (first degree) burn to the side of the patient's mouth¿.Through further assessment, the distributor indicated the event was also reported to the fda by the customer under report number mw5171051, and "the customer has not responded after multiple attempts to get more information.".This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.
Event or Problem Description
A distributor reported on behalf of a customer that the 130318a, electrosurgical handpiece device was used in an unnamed procedure on (b)(6) 2025, and ¿during surgery the cautery the provider was using caused a small (first degree) burn to the side of the patient's mouth¿.Through further assessment, the distributor indicated the event was also reported to the fda by the customer under report number mw5171051, and "the customer has not responded after multiple attempts to get more information.".This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.
Additional Manufacturer Narrative
Correction: block e.1 initial reporter has been updated additional manufacturer narrative: neither the device nor photographic evidence was provided.Therefore, the reported event cannot be verified.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.(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.

• Brand Name: CONMED GOLDLINE
• 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: 22422218
• Report Number: 3007305485-2025-00108
• Device Sequence Number: 12537810
• Product Code: GEI
• UDI-Device Identifier: 20653405056307
• UDI-Public: (01)20653405056307(11)240117(10)202401175
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K791137
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/12/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 130318A
• Device Lot Number: 202401175
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/18/2025
• Supplement Date Received by Manufacturer: 08/08/2025
• Initial Report FDA Received Date: 07/07/2025
• Supplement Report FDA Received Date: 08/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/17/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Patient Sequence Number: 1
• Patient Age: 8 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic