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

Catalog Number	60-8018-SYS
Medical Device Problem Code	Energy Output Problem (1431)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	08/08/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device is not expected to be returned for evaluation and review.However, the complaint investigation is not complete at this time.A supplemental and final report will be filed following the completion of the 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 60-8018-sys, full system 100 - 230 vac 50/60 hz electrosurgical unit (serial number (b)(6)) device was being used during lletz procedure on (b)(6) 2025 when it was reported ¿system 5000 cut worked however when using coag did not effectively stop bleeding in lletz procedure.Both systems did not work patient re-entered hospital 24 hours later via a&e due to excessive bleeding.¿ further assessment questioning has been attempted but to date no further information is available.The procedure was completed with the use of an alternate chemical coagulation device and a 15-minute delay.This report is being raised on the reported injury due to the patient experiencing excessive bleeding.
Additional Manufacturer Narrative
Neither the device nor photographic evidence was provided.Therefore, the reported event can not be verified.The service history was reviewed, and no data was found.A device history review (dhr) review found no abnormalities that would contribute to this reported event.A two-year review of complaint history revealed there has been a total of 9 complaints, regarding 9 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 this electrosurgical unit should be tested by a hospital qualified biomedical technician on a periodic basis to ensure proper and safe operation.It is recommended that examination of the esu be performed at least yearly.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 60-8018-sys, full system 100 - 230 vac 50/60 hz electrosurgical unit (serial number (b)(6) device was being used during lletz procedure on (b)(6) 2025 when it was reported ¿system 5000 cut worked however when using coag did not effectively stop bleeding in lletz procedure.Both systems did not work patient re-entered hospital 24 hours later via a&e due to excessive bleeding.¿ further assessment questioning has been attempted but to date no further information is available.The procedure was completed with the use of an alternate chemical coagulation device and a 15-minute delay.This report is being raised on the reported injury due to the patient experiencing excessive bleeding.

• 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: samantha dewberry ; 525 french road; utica, NY 13502 ; 3152230184
• MDR Report Key: 22904374
• Report Number: 3007305485-2025-00141
• Device Sequence Number: 15431466
• Product Code: GEI
• UDI-Device Identifier: 10653405040194
• UDI-Public: (01)10653405040194(11)230825
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 10/20/2025

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: 60-8018-SYS
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/13/2025
• Supplement Date Received by Manufacturer: 10/14/2025
• Initial Report FDA Received Date: 08/27/2025
• Supplement Report FDA Received Date: 10/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/25/2023
• 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: Hospitalization; Other; Required Intervention
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic