MAUDE Adverse Event Report: CONSOLIDATED MEDICAL EQUIPMENT COMPANY HYFRECATOR 2000; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Catalog Number	7-900-115
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	08/01/2025
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 customer reported that the device, 7-900-115, hyfrecator 2000, 115v/50-60hz, was being used during lipoma excision procedure on (b)(6) 2025 when it was reported, ¿during the procedure, dr.(b)(6) used our hyfrecator which caused two burn marks on the patients left leg.A pt was injured today during a lipoma excision of his right temporal.This device has been used several times by multiple providers and is update with inspection.It is kept securely in a dry location.I am not sure what could be the reason for the malfunction.".Further assessment was requested from the reporter, and they stated that no further information was available.The type of malfunction or relationship between the device and how the burn was caused is not known at this time.This report is being raised due to the reported injury unknown degree of burn to patient.
Event or Problem Description
The customer reported that the device, 7-900-115, hyfrecator 2000, 115v/50-60hz, was being used during lipoma excision procedure on (b)(6) 2025 when it was reported, ¿during the procedure, dr.Jing used our hyfrecator which caused two burn marks on the patients left leg.A pt was injured today during a lipoma excision of his right temporal.This device has been used several times by multiple providers and is update with inspection.It is kept securely in a dry location.I am not sure what could be the reason for the malfunction.".Further assessment was requested from the reporter, and they stated that no further information was available.The type of malfunction or relationship between the device and how the burn was caused is not known at this time.This report is being raised due to the reported injury unknown degree of burn to patient.
Additional Manufacturer Narrative
The device is not being returned and the photographic evidence provided does not appear to verify the complaint; 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.The service history was reviewed and no relationship to this complaint was found.(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 to avoid alternate site burns or potential shock, remove all metal objects from treatment area before using the hyfrecator 2000.The tips of recently activated accessories may be hot enough to burn the patient or ignite flammable material.Temporarily unused active electrodes should be stored in the holder on the hyfrecator 2000 or in an electrically insulated, flame-resistant container to prevent injury due to hot tips or accidental activation of the footswitch.The unused active electrode should never be placed on the patient.When used, the neutral electrode (patient plate) should be reliably attached with the entire surface area in contact with the patient¿s body and as close to the operating field as possible.When not in use, the neutral electrode should be disconnected from the hyfrecator 2000 to avoid accidental burns.We will continue to monitor per regulatory requirements to help ensure patient safety.

• Brand Name: HYFRECATOR 2000
• 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: 23308901
• Report Number: 3007305485-2025-00171
• Device Sequence Number: 4838367
• Product Code: GEI
• UDI-Device Identifier: 10653405031598
• UDI-Public: (01)10653405031598(11)170608
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K970493
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 11/17/2025

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: 7-900-115
• 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: 09/26/2025
• Supplement Date Received by Manufacturer: 10/17/2025
• Initial Report FDA Received Date: 10/16/2025
• Supplement Report FDA Received Date: 11/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/08/2017
• Is the Device Labeled for Single Use? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic