MAUDE Adverse Event Report: CONSOLIDATED MEDICAL EQUIPMENT COMPANY SYSTEM 2450, 120V; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Catalog Number	60-2450-120
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	07/25/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The sales representative reported on behalf of the customer that the 60-2450-120, system 2450, 120v, was being used during an unknown procedure on (b)(6) 2023.When it was reported, ¿during procudure nurse was burned.The nurse put hand between grounding pad and patient per bio med.¿.There was no report of medical intervention or hospitalization for the user, only burned finger tips were red for a while.There was no report of injury, medical intervention, or hospitalization for the patient.Further assessment information from the reporter found that there was no malfunction with the device, user error caused the incident.Conmed has offered further education for the staff.No other information was available per the reporter.This report is being raised due to the reported injury for unknown degree of burn to the user.
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 for trends through the complaint system to assure patient safety.H3 other text : device not yet received.
Event or Problem Description
The sales representative reported on behalf of the customer that the 60-2450-120, system 2450, 120v, was being used during an unknown procedure on (b)(6) 2023 when it was reported, ¿during procudure nurse was burned.The nurse put hand between grounding pad and patient per bio med.¿.There was no report of medical intervention or hospitalization for the user, only burned finger tips were red for a while.There was no report of injury, medical intervention, or hospitalization for the patient.Further assessment information from the reporter found that there was no malfunction with the device, user error caused the incident.Conmed has offered further education for the staff.No other information was available per the reporter.This report is being raised due to the reported injury for unknown degree of burn to the user.
Additional Manufacturer Narrative
No fault was found with the device.The unit was checked and met all acceptance criteria.All tests per specifications (b)(4) and (b)(4) passed.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.The service history was reviewed, and no previous data was found.(b)(4).Per the instructions for use, the user is advised that safe and effective electrosurgery is dependent not only on equipment design, but also on factors under the control of the operator.It is important that the instructions supplied with this equipment be read, understood, and followed in order to ensure safe and effective use of the equipment.The system 2450 is capable of causing physiological effects, including burns to the patient or operator.Only properly qualified and trained operators should perform electrosurgery.The operator and their support personnel must be diligent in assuring that the esu is properly configured and that proper settings are used.The esu must be in a location that assures that the operator or their support personnel can readily verify the settings.The system 2450 is capable of causing physiological effects, including burns to the patient or operator.We will continue to monitor for trends through the complaint system to assure patient safety.

• Brand Name: SYSTEM 2450, 120V
• 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: john berga ; 11311 concept blvd; largo, FL 33773 ; 7273995358
• MDR Report Key: 17735395
• Report Number: 3007305485-2023-00204
• Device Sequence Number: 20517296
• Product Code: GEI
• UDI-Device Identifier: 10653405061526
• UDI-Public: (01)10653405061526(11)210219
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K052009
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 10/26/2023

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: 60-2450-120
• 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: 08/24/2023
• Supplement Date Received by Manufacturer: 10/11/2023
• Initial Report FDA Received Date: 09/13/2023
• Supplement Report FDA Received Date: 10/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/19/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: GROUNDING PAD; GROUNDING PAD
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic