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 11/13/2023

Event Type  malfunction  

Event Description

The distributor reported on behalf of their customer that the 410-2000, cga, surefit ground pad with 10ft cabel, 100/case, was being used during an unknown procedure on (b)(6) 2023 when it was reported, ¿after the improved product, the counter plate came off in the middle of the surgery and the body's peeling alarm went off.¿ there was no report of injury, medical intervention, or hospitalization for the patient or user.The procedure was completed as planned using an alternate same device.Further assessment found that the device peeled off the patient during use.This report is being raised due to the reported 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.We will continue to monitor for trends through the complaint system to assure patient safety.H3 other text : device not yet received.

Event Description

The distributor reported on behalf of their customer that the 410-2000, cga, surefit ground pad with 10ft cabel, 100/case, was being used during an unknown procedure on (b)(6) 2023 when it was reported, ¿after the improved product, the counter plate came off in the middle of the surgery and the body's peeling alarm went off.¿ there was no report of injury, medical intervention, or hospitalization for the patient or user.The procedure was completed as planned using an alternate same device.Further assessment found that the device peeled off the patient during use.This report is being raised due to the reported malfunction with potential for injury upon reoccurrence.

Manufacturer Narrative

Received one 410-2000 in opened original packaging.Lot number was verified.Performed a visual inspection, there were no obvious signs of abnormalities or defects.A functional inspection could not be performed due to the device being received in opened packaging and the gel being exposed to air for an extended period of time.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.A two-year review of complaint history revealed there has been a total of 120 complaints, regarding 1,684 devices, for this device family and failure mode.During this same time frame (b)(4) 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: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.

• 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: 18370963
• MDR Text Key: 331364969
• Report Number: 3007305485-2023-00254
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 10653405033837
• UDI-Public: (01)10653405033837(17)231130(10)202111304
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K120322
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Distributor
• Reporter Occupation: Administrator/Supervisor
• 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 Received: 12/21/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2023
• Device Catalogue Number: 410-2000
• Device Lot Number: 202111304
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Manufacturer Received: 01/17/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/30/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Ethnicity: Non Hispanic