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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 Type  malfunction  
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 distributor reported on behalf of the customer that the device, 410-2000 cga, surefit ground pad with 10ft cabel, 100/case was being used on an unknown date and " we have been having problems with the conmed bovie grounding pads that we are getting in our packs.They are not sticking well to most patients and causing issues mid case¿.There was no impact or injury to the patient or user.There was no report of medical intervention or any prolonged hospitalization for the patient.Further assessment found that no other information was known.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.
 
Manufacturer Narrative
The device is not being returned and no photographic evidence was provided.Therefore, a device malfunction cannot be verified.A dhr review cannot not be conducted as no lot number was provided.A two-year lot history review cannot be conducted as no lot number was provided.A two-year review of complaint history revealed there has been a total of 53 complaints, regarding 492 devices, for this device family and failure mode.During this same time frame 10,373,340 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 ifu, the user is advised to not attempt to select a well vascularized site in close proximity to the surgical site (anterior arm or thigh is recommended).Avoid placement on bony prominence, skin lesions or folds, tattoos, scars, metal prosthesis or near ecg electrodes and cables.Do not apply where fluid might pool.Always use the largest size pad per patient weight guidelines which can be properly applied to the site: adult products are for use on patients weighing more than 15 kg.Pediatric pads are for use on patients weighing between 5 and 15 kg.Prepare the skin at the application site according to facility protocol.If no protocol exists, clip excessive hair at application site, clean and disinfect area to remove oils, lotions, etc., and allow to dry.Do not open package until ready to apply to skin.Inspect the pad and cable.Do not use if product is expired or apparently damaged.Check expiration date on package.This issue will continue to be monitored through the complaint system to assure patient safety.
 
Event Description
The distributor reported on behalf of the customer that the device, 410-2000 cga, surefit ground pad with 10ft cabel, 100/case was being used on an unknown date and " we have been having problems with the conmed bovie grounding pads that we are getting in our packs.They are not sticking well to most patients and causing issues mid case¿.There was no impact or injury to the patient or user.There was no report of medical intervention or any prolonged hospitalization for the patient.Further assessment found that no other information was known.This report is being raised on the basis of 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
samantha dewberry
525 french rd
utica, NY 13502
3152230184
MDR Report Key14917680
MDR Text Key303553623
Report Number3007305485-2022-00092
Device Sequence Number1
Product Code GEI
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 User Facility,Distributor
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 08/11/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/05/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number410-2000
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received08/10/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Patient Sequence Number1
Patient EthnicityNon Hispanic
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