MAUDE Adverse Event Report: CONSOLIDATED MEDICAL EQUIPMENT COMPANY CGA, SUREFIT GROUND PAD WITH 10FT CABEL, 100/CASE; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Catalog Number 410-2000

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Burn(s) (1757)

Event Date 08/29/2022

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.This issue will continue to be monitored through the complaint system to assure patient safety.

Event Description

The sales representative reported on behalf of the customer that the 410-2000, cga, surefit ground pad, was being used during a beast lumpectomy on approximately (b)(6) 2022 when it was reported,¿ one of our surgeons reported this week, that they had sustained a pin point burn to their hand during a procedure.She checked her gloves for a hole and nothing was found.¿.There was no report of injury, medical intervention, or hospitalization for the patient.Further assessment questioning found that the procedure was completed with no harm to the patient.The surgeon was using a bovie and stainless-steel forceps at the time to cauterize a vessel.The user was single gloved.There was no information on the degree of burn to the user; however, there was no report of medical intervention or hospitalization for the user.Per the reporter, "after this incident, we inspected the surefit pads and had our biomed technician also look at them.The pads appear to have little gel on them and the adhesiveness of the pad is minimal." the patient is listed as status of ¿normal¿.The conmed 60-2450-120, system 2450, 120v, will be listed as the concomitant device used with the pads in this procedure.The manufacturer of the forceps and bovie is unknown.This report is being raised on the basis of injury due to unknown degree of burn.

Event Description

The sales representative reported on behalf of the customer that the 410-2000, cga, surefit ground pad, was being used during a beast lumpectomy on approximately (b)(6) 2022 when it was reported,¿ one of our surgeons reported this week, that they had sustained a pin point burn to their hand during a procedure.She checked her gloves for a hole and nothing was found.¿.There was no report of injury, medical intervention, or hospitalization for the patient.Further assessment questioning found that the procedure was completed with no harm to the patient.The surgeon was using a bovie and stainless-steel forceps at the time to cauterize a vessel.The user was single gloved.There was no information on the degree of burn to the user; however, there was no report of medical intervention or hospitalization for the user.Per the reporter, "after this incident, we inspected the surefit pads and had our biomed technician also look at them.The pads appear to have little gel on them and the adhesiveness of the pad is minimal." the patient is listed as status of ¿normal¿.The conmed 60-2450-120, system 2450, 120v, will be listed as the concomitant device used with the pads in this procedure.The manufacturer of the forceps and bovie is unknown.This report is being raised on the basis of injury due to unknown degree of burn.

Manufacturer Narrative

To date the device has not been received for evaluation and no photographic evidence was provided.Therefore, a device malfunction cannot be verified.The manufacturing documents from the device history record have not been reviewed because the lot number is not known.The lot history review was not conducted because the lot number is not known.(b)(4).Per the instructions for use, the user is advised the surefit dual dispersive electrodes are not recommended for use in high current procedures where the activation time and current exceed 30 a2 s in any 60 second period.Use of surefit dual dispersive electrodes on adults in high current procedures exceeding 700 ma and maximum cumulative activation time of 60 seconds in any 120 second period can result in electrosurgical burns or poor electrosurgical performance.Use of surefit dual dispersive electrodes on pediatric patients in high current procedures exceeding 500 ma and maximum cumulative activation time of 60 seconds in any 120 second period can result in electrosurgical burns or poor electrosurgical performance.This issue will continue to be monitored through the complaint system to assure patient safety.

• Brand Name: CGA, SUREFIT GROUND PAD WITH 10FT CABEL, 100/CASE
• 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: john berga ; 11311 concept blvd; largo, FL 33773 ; 7273995358
• MDR Report Key: 15454010
• MDR Text Key: 300220974
• Report Number: 3007305485-2022-00147
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K120322
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date: 10/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/20/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 410-2000
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/04/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1
• Treatment: 60-2450-120, SYSTEM 2450, 120V
• Patient Outcome(s): Other
• Patient Ethnicity: Non Hispanic