MAUDE Adverse Event Report: CONSOLIDATED MEDICAL EQUIPMENT COMPANY GROUND PAD TDS ADULT END CONN.; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Catalog Number 400-2100

Device Problem Insufficient Information (3190)

Patient Problem Burn(s) (1757)

Event Date 04/03/2024

Event Type  Injury  

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 Description

A distributor reported on behalf of a customer that the 400-2100, ground pad tds adult end conn.Device was being used during a procedure for malignant tumor of the stomach on (b)(6) 2003, and ¿a burn could be observed on the left thigh; the corresponding cleaning was carried out and tetrapropylene was placed to improve healing.¿.The procedure was completed without the use of an alternate device.Upon further investigation the customer indicated that no more information was available.There was no report of further medical/surgical intervention, or extended hospitalization for the patient.This report is being raised due to the reported injury of a burn of unknown degree to the patient.

Event Description

A distributor reported on behalf of a customer that the 400-2100, ground pad tds adult end conn.Device was being used during a procedure for malignant tumor of the stomach on (b)(6) 2024, and "a burn could be observed on the left thigh; the corresponding cleaning was carried out and terpropyl was placed to improve healing." the procedure was completed without the use of an alternate device.Upon further investigation the customer indicated that no more information was available.There was no report of further medical/surgical intervention, or extended hospitalization for the patient.This report is being raised due to the reported injury of a burn of unknown degree to the patient.

Manufacturer Narrative

The device will not be returned, and no photographic evidence was provided.Therefore, a device malfunction 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.(b)(4).Per the instructions for use, the user is advised the following: some equipment and/or techniques fall outside the intended use of standard electrosurgery dispersive electrodes, such as the application of high current, long activation times, or use of conductive fluid (e.G.Tissue ablation, joint ablation, etc.).In these high-current procedures, there is a risk that excess heat may build up in standard dispersive electrodes which may result in patient injury or burns.Conmed surefit dual dispersive electrodes have not been tested for use during high current procedures and are not recommended for non-standard electrosurgical applications.Always use the lowest power settings to achieve the desired surgical effect.Conductive parts of the pad and associated connectors should not contact any other conductive parts including earth, as this contact may increase the risk of harm to the patient or operator.Avoid skin-to-skin contact when positioning the patient, using dry gauze where necessary.We will continue to monitor for trends through the complaint system to assure patient safety.

• Brand Name: GROUND PAD TDS ADULT END CONN.
• Type of Device: 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: 19117692
• MDR Text Key: 340293313
• Report Number: 3007305485-2024-00055
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 10653405006992
• UDI-Public: (01)10653405006992(17)241101(10)202211024
• Combination Product (y/n): N
• Reporter Country Code: EC
• PMA/PMN Number: K120476
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/10/2024

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
• Device Operator: Health Professional
• Device Catalogue Number: 400-2100
• Device Lot Number: 202211024
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/09/2024
• Initial Date FDA Received: 04/16/2024
• Supplement Dates Manufacturer Received: 05/07/2024
• Supplement Dates FDA Received: 05/10/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/02/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 51 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic