MAUDE Adverse Event Report: CONSOLIDATED MEDICAL EQUIPMENT COMPANY SYSTEM 5000; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Catalog Number	60-8018-SYS
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Burn(s) (1757); Shock (2072)
Date of Event	02/18/2025
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.We will continue to monitor per regulatory requirements to help ensure patient safety.
Event or Problem Description
The customer reported that the device, 60-8018-sys, full system 100 - 230 vac 50/60 hz electrosurgical unit, was being used during an unknown procedure on (b)(6) 2025 when it was reported, ¿staff member received an electric shock as cable not holding machine.Injury, shock/burn.¿.There was no report of medical intervention or hospitalization for the patient or the user.This caused a 5-minute delay in the procedure; however, the procedure was reported as being completed.There was no allegation of malfunction against the conmed device.Further assessment has been requested of the reporter; however, the reporter has not responded to date.This report is being raised due to the reported injury of user receiving a shock and unknown degree of burn.
Additional Manufacturer Narrative
The device has not been returned to date and photographic evidence was not provided.Therefore, the reported event can not be verified.If the device is returned at a later date, the investigation may be updated and reanalyzed.A device history review (dhr) review found no abnormalities that would contribute to this reported event.The service history was reviewed and no relationship to this complaint was found.A two-year review of complaint history revealed there has been a total of (b)(4) complaints, regarding 21 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 that activating the system 5000¿ in other than its normal operating position impairs the heat dissipation capability of the heat sink.Since the clinical use of electrosurgical units is intermittent in nature with duty cycles on the order of 10%, this esu is not designed to operate for extended periods of continuous output.When testing, it is recommended that duty cycles be limited to 10 seconds of activation with delays of 30 seconds between activations.Improperly connecting test equipment can cause electric shock and destruction of equipment.To avoid the risk of electric shock, this equipment must only be connected to a supply mains with protective earth.We will continue to monitor per regulatory requirements to help ensure patient safety.
Event or Problem Description
The customer reported that the device, 60-8018-sys, full system 100 - 230 vac 50/60 hz electrosurgical unit, was being used during an unknown procedure on (b)(6) 2025 when it was reported, ¿staff member received an electric shock as cable not holding machine.Injury, shock/burn.¿.There was no report of medical intervention or hospitalization for the patient or the user.This caused a 5-minute delay in the procedure; however, the procedure was reported as being completed.There was no allegation of malfunction against the conmed device.Further assessment has been requested of the reporter; however, the reporter has not responded to date.This report is being raised due to the reported injury of user receiving a shock and unknown degree of burn.

• Brand Name: SYSTEM 5000
• 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: 21771912
• Report Number: 3007305485-2025-00061
• Device Sequence Number: 15503957
• Product Code: GEI
• UDI-Device Identifier: 10653405040194
• UDI-Public: (01)10653405040194(11)171116
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K020186
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/13/2025

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 60-8018-SYS
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/13/2025
• Supplement Date Received by Manufacturer: 04/30/2025
• Initial Report FDA Received Date: 04/04/2025
• Supplement Report FDA Received Date: 05/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/16/2017
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic