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

Catalog Number	60-2450-230
Medical Device Problem Code	Unintended Electrical Shock (4018)
Health Effect - Clinical Codes	Shock (2072); Electric Shock (2554)
Date of Event	06/09/2025
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
The sales representative reported on behalf of the customer that the 60-2450-230 system 2450 230 - 240 vac 50/60 hz electrosurgical unit was being used on (b)(6)2025 and ¿the operator has received an electric shock to his finger¿.There was no impact or injury for the patient or user.The procedure was completed with an alternate device.A good faith effort has been completed; however, to date no new information has been received.This report is being raised due to the reported malfunction with potential for injury upon reoccurrence.
Event or Problem Description
The sales representative reported on behalf of the customer that the 60-2450-230 system 2450 230 - 240 vac 50/60 hz electrosurgical unit was being used on 9jun25 and ¿the operator has received an electric shock to his finger¿.There was no impact or injury for the patient or user.The procedure was completed with an alternate device.A good faith effort has been completed; however, to date no new information has been received.This report is being raised due to the reported malfunction with potential for injury upon reoccurrence.
Additional Manufacturer Narrative
Correction: health effect - clinical code section h6 corrected to electric shock manufacturer narrative: reported event of a device malfunction resulting in the operator receiving an electric shock to his finger is inconclusive.An evaluation of the returned device could not duplicate the reported event.The result is that the machine functions as intended.The service history was reviewed, and no data was found.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 review of complaint history revealed there has been a total of 11 reports, regarding 11 devices, for this device family and failure mode.During this same time frame 25,073 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 0.0004.Per the instructions for use, the user is advised the following: there are no user serviceable parts in this equipment.Improper servicing of the equipment could result in improper operation and present a risk of electric shock.Improperly connecting test equipment can cause electric shock and destruction of equipment.To avoid risk of electric shock, this equipment must only be connected to a supply main with protective earth.We will continue to monitor per regulatory requirements to help ensure patient safety.

• Brand Name: SYSTEM 2450
• 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: robin drum ; 11311 concept blvd; largo, FL 33773 ; 8653881978
• MDR Report Key: 22308473
• Report Number: 3007305485-2025-00104
• Device Sequence Number: 12925493
• Product Code: GEI
• UDI-Device Identifier: 20653405058165
• UDI-Public: (01)20653405058165(11)240423
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K052009
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 07/23/2025

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: 60-2450-230
• 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: 06/09/2025
• Supplement Date Received by Manufacturer: 07/18/2025
• Initial Report FDA Received Date: 06/23/2025
• Supplement Report FDA Received Date: 07/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/23/2024
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic