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.

Event Description

The customer reported that the aes-1 was being used on 20dec23 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 device appears to work, but the thermal sensor is disabled¿.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

The evaluation found that the temperature monitor was disabled in the menu and the temperature was set at 50°c.If the temperature monitor is disabled, the system won't display the current the temperature on the probe and it won't give a warning if the temperature of the probe reaches the temperature set in the monitor (in this case 50°c).With the temperature monitor enabled, the temperature sensor works within the specifications and the temperature is displayed correctly on the screen.The repair was completed.The final test was completed and met all specifications.An adverse event meeting was held where it was discussed that having the temperature monitor disabled could had caused the issue.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.(b)(4).Per the instructions for use, the user is advised the following: touch temperature icons near the bottom of the touchscreen to enable or disable the temperature display on the bipolar main run screen.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 device appears to work, but the thermal sensor is disabled¿.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: 18476644
• MDR Text Key: 332451197
• Report Number: 3007305485-2024-00006
• 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: 10/01/2014
• 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