MAUDE Adverse Event Report: CONSOLIDATED MEDICAL EQUIPMENT COMPANY ADVANCED ENERGY GENERATOR; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Catalog Number AES-1

Device Problem Insufficient Information (3190)

Patient Problem Burn(s) (1757)

Event Date 12/20/2023

Event Type  Injury  

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 for trends through the complaint system to assure patient safety.H3 other text: device not yet received.

Event Description

The customer reported that the aes-1 was being used on (b)(6) 2023 during a shoulder arthroscopy and ¿the situation is that when they were using the aes-1 the saline solution became very hot and burned the cutaneous area around the arthroscopic portal, as the liquid came out.The hospital does not know which of its devices were used, so we removed all devices.We also did an internal test and the results were these: sn: (b)(6): the touch screen is broken, the parameters can not be changed.We could not carry out the test.¿.Per further assessment the degree of burn is unknown and there was no medical/surgical intervention or prolonged hospitalization required for the patient/user.The procedure was completed without an alternate device.This report is being raised due to the reported injury of burn where the degree of burn is unknown.

Manufacturer Narrative

Reported event of ¿saline solution became very hot and burned the cutaneous area¿ was confirmed.The evaluation found the touch screen is broken, the parameters can not be changed.The preventative maintenance (pm) was overdue.The repair was completed.The final test was completed and met all specifications.The service history was reviewed and no relationship to this complaint was found.A device history record review was not conducted as the device has been in the field greater than 12 months.A two-year review of complaint history revealed there has been a total of 4 reports, regarding 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: the proper use and placement of a dispersive electrode is a key element in the safe and effective use of electrosurgery in monopolar procedures, particularly in the prevention of burns.Follow manufacturer¿s directions and recommended practices for the preparation, placement, use, surveillance, and removal of any return electrode supplied for use with this electrosurgical unit.The aes-1 generator shall be returned to conmed customer service department (refer to ¿5.1 assistance and repair¿) every 12 months for servicing.We will continue to monitor for trends through the complaint system to assure patient safety.

Event Description

The customer reported that the aes-1 was being used on (b)(6) 2023 during a shoulder arthroscopy and ¿the situation is that when they were using the aes-1 the saline solution became very hot and burned the cutaneous area around the arthroscopic portal, as the liquid came out.The hospital does not know which of its devices were used, so we removed all devices.We also did an internal test and the results were these: sn: (b)(6): the touch screen is broken, the parameters can not be changed.We could not carry out the test.¿ per further assessment the degree of burn is unknown and there was no medical/surgical intervention or prolonged hospitalization required for the patient/user.The procedure was completed without an alternate device.This report is being raised due to the reported injury of burn where the degree of burn is unknown.

• Brand Name: ADVANCED ENERGY GENERATOR
• 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: robin drum ; 11311 concept blvd; largo, FL 33773 ; 8653881978
• MDR Report Key: 18476665
• MDR Text Key: 332491919
• Report Number: 3007305485-2024-00007
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K140578
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/19/2024

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: AES-1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/20/2023
• Initial Date FDA Received: 01/09/2024
• Supplement Dates Manufacturer Received: 02/14/2024
• Supplement Dates FDA Received: 02/19/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/29/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic