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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CONSOLIDATED MEDICAL EQUIPMENT COMPANY CGA, SUREFIT GROUND PAD WITH 10FT CABEL, 100/CASE; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
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CONSOLIDATED MEDICAL EQUIPMENT COMPANY CGA, SUREFIT GROUND PAD WITH 10FT CABEL, 100/CASE; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES Back to Search Results
Catalog Number 410-2000
Device Problem Device Dislodged or Dislocated (2923)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/05/2023
Event Type  malfunction  
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
The sales representative reported on behalf of the customer that the 410-2000, cga, surefit ground pad with 10ft cabel, 100/case, was being used during a hysterectomy procedure on 5dec23 when it was reported, ¿¿adhesive coming undone on the patient.".There was no report of injury, medical intervention, or hospitalization for the patient.Further assessment questioning found that the procedure was completed using a competitor device causing a 3-minute delay.This report is being raised due to the reported malfunction with potential for injury upon reoccurrence.
 
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.This is the only complaint for this lot number and failure mode within the past two years.(b)(4).Per the instructions for use, the user is advised the following: 3.Prepare the skin at the application site according to facility protocol.If no protocol exists, clip excess hair at application site, clean and disinfect area to remove oils, lotions, etc., and allow to dry thoroughly.4.Do not open package until ready to apply pad to skin.Inspect the pad and cable.Do not use if product is expired or apparently damaged.Check expiration date on package.5.After patient is in the final position, carefully remove the pad from the disposable liner by grasping the pad from the pad pull tab (located at the wire attachment end of the pad) and peeling the pad diagonally from the disposable liner.Avoid excess skin or finger contact with the adhesive or gel surface prior to application.6.Pad may be applied with any side perpendicular to the direction of current flow from the operative site.7.Apply the pad firmly to skin, ensuring full adhesion of the pad gel and adhesive, and full pad contact with patient¿s skin.We will continue to monitor for trends 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 with 10ft cabel, 100/case, was being used during a hysterectomy procedure on 5dec23 when it was reported, ¿¿adhesive coming undone on the patient.".There was no report of injury, medical intervention, or hospitalization for the patient.Further assessment questioning found that the procedure was completed using a competitor device causing a 3-minute delay.This report is being raised due to the reported malfunction with potential for injury upon reoccurrence.
 
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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 Key18494261
MDR Text Key333099757
Report Number3007305485-2024-00009
Device Sequence Number1
Product Code GEI
UDI-Device Identifier10653405033837
UDI-Public(01)10653405033837(17)250126(10)202301274
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K120322
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,User Facility,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 02/01/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/11/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number410-2000
Device Lot Number202301274
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/17/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/27/2023
Is the Device Single Use? Yes
Patient Sequence Number1
Patient EthnicityNon Hispanic
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