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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  
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 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.
 
Manufacturer Narrative
The device is not being returned and no photographic evidence was provided; therefore, a device malfunction cannot be verified.A two-year lot history review cannot be conducted as a lot number was not provided.A device history record review cannot be conducted as a lot number was not provided.A two-year review of complaint history revealed there has been a total of 119 reports, regarding 683 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 instructions for use, the user is advised the following: 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 may pool.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.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
robin drum
11311 concept blvd
largo, FL 33773
8653881978
MDR Report Key15128753
MDR Text Key301500529
Report Number3007305485-2022-00113
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 09/14/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/29/2022
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 Received08/24/2022
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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