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

Catalog Number	60-2450-220
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Partial thickness (Second Degree) Burn (2694)
Date of Event	05/29/2024
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 for trends through the complaint system to assure patient safety.
Event or Problem Description
The distributor reported on behalf of the customer that the device, 60-2450-220, system 2450, 220v, was being used on (b)(6) 2024 during a blepharoplasty) and ¿when activating the scalpel, according to the medical team, the scalpel pen had a very strong flame, the blend was at a power of 20 and lowered to 15 and even so the flame when activating the pen was strong.The scalpel carriage was changed.The blend was reduced to 10, and when using the scalpel pen, a flame of fire formed on the patient's face.The patient is stable, receiving due care administered by the hospital, the burns are 2nd degree in the region, continuing to the nasal septum.Pen used in our equipment: scalpel pen lot: 240083 brand: gabisa medical internacional s.A.¿.The procedure was completed with a valleylab medtronic and there was a 3 hour delay.Per further assessment, it was found that burn treatment with special coverings was necessary.As of 14jun24 the patient was in treatment of the injury and ent evaluation.The patent did not require prolonged hospitalization.This report is being raised on the basis of injury due to device with no report of malfunction being used during a procedure where the patient experienced a 2nd degree burn caused by a competitor's device.
Additional Manufacturer Narrative
The device will not be returned and no photographic evidence was provided therefore, a device malfunction cannot be verified.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 (b)(4) reports, regarding (b)(4) 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 the following: electrosurgery should never be performed in the presence of flammable anesthetics, flammable prep solutions or drapes, oxidizing gases such as nitrous oxide (n2o) or in oxygen-enriched environments.The risk of igniting flammable gases or other materials is inherent in electrosurgery and cannot be eliminated by device design.Precautions must be taken to restrict flammable materials and substances from the electrosurgical site.They may be present in the form of an anesthetic, life support, skin preparation agent, produced by natural processes within body cavities or originate in surgical drapes, tracheal tubes or other materials.The ifu also advises the user that if unsure of the proper settings, use low power settings initially and make adjustments intraoperatively according to the surgeon¿s requests.Use of a written record of each surgeon¿s preferred power setting for various procedures will expedite subsequent pre-op setup.We will continue to monitor for trends through the complaint system to assure patient safety.
Event or Problem Description
Update: per information received on 20jun24 there was no report from the hospital for equipment alarms sounding during the procedure.The distributor reported on behalf of the customer that the device, 60-2450-220, system 2450, 220v, was being used on (b)(6) 2024 during a blepharoplasty) and ¿when activating the scalpel, according to the medical team, the scalpel pen had a very strong flame, the blend was at a power of 20 and lowered to 15 and even so the flame when activating the pen was strong.The scalpel carriage was changed.The blend was reduced to 10, and when using the scalpel pen, a flame of fire formed on the patient's face.The patient is stable, receiving due care administered by the hospital, the burns are 2nd degree in the region, continuing to the nasal septum.Pen used in our equipment: scalpel pen lot: 240083 brands: gabisa medical internacional s.A.¿.The procedure was completed with a valleylab medtronic and there was a 3 hour delay.Per further assessment, it was found that burn treatment with special coverings was necessary.As of (b)(6) 2024 the patient was in treatment of the injury and ent evaluation.The patent did not require prolonged hospitalization.This report is being raised on the basis of injury due to device with no report of malfunction being used during a procedure where the patient experienced a 2nd degree burn caused by a competitor's device.

• 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: 19578251
• Report Number: 3007305485-2024-00087
• Device Sequence Number: 19847990
• Product Code: GEI
• UDI-Device Identifier: 10653405058151
• UDI-Public: (01)10653405058151(11)231023
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K052009
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/22/2024

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: 60-2450-220
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/03/2024
• Supplement Date Received by Manufacturer: 07/18/2024
• Initial Report FDA Received Date: 06/20/2024
• Supplement Report FDA Received Date: 07/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/23/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SCALPEL PEN LOT: 240083 BRAND: GABISA MEDICAL.; SCALPEL PEN LOT: 240083 BRAND: GABISA MEDICAL.; VALLEYLAB MEDTRONIC.; VALLEYLAB MEDTRONIC.
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Age: 48 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic