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 No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/08/2022

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.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 with 10ft cabel, 100/case was being used during an unknown procedure on (b)(6) 2022 when it was reported that ¿we have been having problems with the new conmed dual dispersive electrodes ref 410-2000 here at the user facility.The circulators are reporting that the pads do not stay on the patient very well, especially if the patient is positioned any way other than supine.¿ further assessment found the pads were used during surgery and that the pads had to be replaced with alternate pads when they were found to be not sticking.It was reported that the patient was not injured, and that no medical/surgical intervention or extended hospitalization was required for the patient.The patient was said to be "safe and healthy".This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.

Manufacturer Narrative

Correction: on the initial mdr the original awareness date should have been 8june22 not what was initially filed as 10june22.Manufacturer narrative: the device is not being 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.A two-year lot history review shows this is the only complaint for this lot number and failure mode.A two-year review of complaint history revealed there has been a total of 41 complaints, regarding 471 devices, for this device family and failure mode.During this same time frame 10,093,860 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 0.000047.Per the instructions for use, the user is advised 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 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 an unknown procedure on (b)(6) 2022 when it was reported that ¿we have been having problems with the new conmed dual dispersive electrodes ref 410-2000 here at the user facility.The circulators are reporting that the pads do not stay on the patient very well, especially if the patient is positioned any way other than supine.¿ further assessment found the pads were used during surgery and that the pads had to be replaced with alternate pads when they were found to be not sticking.It was reported that the patient was not injured, and that no medical/surgical intervention or extended hospitalization was required for the patient.The patient was said to be "safe and healthy".This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.

• 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: courtney pomichter ; 525 french rd; utica, NY 13502 ; 3156243170
• MDR Report Key: 14916774
• MDR Text Key: 301500345
• Report Number: 3007305485-2022-00091
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 10653405033837
• UDI-Public: (01)10653405033837(17)240218(10)202202185
• 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: Health Professional,User Facility,Company Representative
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date: 07/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/05/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/18/2024
• Device Catalogue Number: 410-2000
• Device Lot Number: 202202185
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/08/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/18/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Ethnicity: Non Hispanic