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

Catalog Number	60-2450-120
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	Partial thickness (Second Degree) Burn (2694)
Date of Event	05/19/2025
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
A customer reported that the device, 60-2450-120, system 2450 120 vac 50/60 hz electrosurigcal unit, was used in a breast lumpectomy; with sentinel node dissection and lymphatic mapping procedure on (b)(6) 2025, and ¿patient received two dime sized areas of a flat white colored area that almost resembled a blister but no fluid under it from conmed 2450 esu & elctrosrgical pencil¿.The procedure was completed without the use of an alternate device, the ¿area was dressed with antibioticointment and a telfa dressing¿ and the patient¿s status was reported as ¿good¿.Further assessment found a medline pencil was in use.The event occurred "just after incision was made.Md was cauterizing and she was using the sponge to mop up bleeders and this is when they noticed a raytec was burning.The physician says she felt the pencil was running 'a bit hot¿ that day, so they turned the settings down a little.On this particular case the settings were set to spray at 45/45.This was not her normal setting and the staff said they did not set it to that setting.They feel the spray button must have been pushed accidentally.Md performing the surgery documented that patient sustained a burn.In my interview with the surgeon she stated to me this could be a 1st or 2nd degree burn.On post op follow up visit on (b)(6), md did not document anything about a burn to the patient.States that patient is healing well and no signs and symptoms of infection.As of on (b)(6) patient is doing well with no issues per md documentation.Her next follow up visit will be in 5 months and will have a bilateral mammogram.No new orders for medications/treatment were given." this report is being raised due to the reported injury of a first- or second-degree burn incurred by the patient.
Additional Manufacturer Narrative
An evaluation of the returned device found no fault.The unit met all specifications; however, an additional problem was found: the front bezel is broken.The preventive maintenance was completed.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).Per the instructions for use, the user is advised that the system 2450 is capable of causing physiological effects, including burns to the patient or operator.The electrodes of recently activated accessories may be hot enough to burn the patient or ignite surgical drapes or other flammable material.We will continue to monitor per regulatory requirements to help ensure patient safety.
Event or Problem Description
A customer reported that the device, 60-2450-120, system 2450 120 vac 50/60 hz electrosurigcal unit, was used in a breast lumpectomy; with sentinel node dissection and lymphatic mapping procedure on (b)(6) 2025, and "patient received two dime sized areas of a flat white colored area that almost resembled a blister but no fluid under it from conmed 2450 esu and elctrosrgical pencil".The procedure was completed without the use of an alternate device, the "area was dressed with antibioticointment and a telfa dressing" and the patient¿s status was reported as "good".Further assessment found a medline pencil was in use.The event occurred, "just after incision was made.Md was cauterizing and she was using the sponge to mop up bleeders and this is when they noticed a raytec was burning.The physician says she felt the pencil was running 'a bit hot¿ that day, so they turned the settings down a little.On this particular case the settings were set to spray at 45/45.This was not her normal setting and the staff said they did not set it to that setting.They feel the spray button must have been pushed accidentally.Md performing the surgery documented that patient sustained a burn.N my interview with the surgeon she stated to me this could be a 1st or 2nd degree burn.On post op follow up visit on 5/30, md did not document anything about a burn to the patient.States that patient is healing well and no signs and symptoms of infection.As of 5/30 patient is doing well with no issues per md documentation.Her next follow up visit will be in 5 months and will have a bilateral mammogram.No new orders for medications/treatment were given.".This report is being raised due to the reported injury of a first- or second-degree burn incurred by the patient.

• 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: beth madeline ; 11311 concept blvd; largo, FL 33773 ; 7274708358
• MDR Report Key: 22148618
• Report Number: 3007305485-2025-00095
• Device Sequence Number: 7849220
• Product Code: GEI
• UDI-Device Identifier: 10653405061526
• UDI-Public: (01)10653405061526(11)190108
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 06/30/2025

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: 60-2450-120
• 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: 05/20/2025
• Supplement Date Received by Manufacturer: 06/25/2025
• Initial Report FDA Received Date: 06/05/2025
• Supplement Report FDA Received Date: 06/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/08/2019
• 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
• Concomitant Medical Products and Therapy/Usage Dates: MEDLINE PENCIL; MEDLINE PENCIL
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic