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 07/04/2022

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 customer reported that the device, 410-2000, cga, surefit ground pad was being used on (b)(6) 2022 and ¿the item is taken directly from the package and applied to the skin, but quickly dries, and loses it's adherence to the skin.The cautery machine recognizes the increased resistance and stops working.We then have to replace the cautery pad, as it's essential for the use of cautery during surgery.We have had to replace the cautery pad 3 times over the course of a single surgical case.¿ there was no injury or impact to the patient.Further assessment has been sent; however, to date a response has not been received.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.

Manufacturer Narrative

Reported event is inconclusive.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.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 53 reports, 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 instructions for use, the user is advised the following: 1.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.2.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.3.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.4.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 customer reported that the device, 410-2000, cga, surefit ground pad was being used on 4jul22 and ¿the item is taken directly from the package and applied to the skin, but quickly dries, and loses it's adherence to the skin.The cautery machine recognizes the increased resistance and stops working.We then have to replace the cautery pad, as it's essential for the use of cautery during surgery.We have had to replace the cautery pad 3 times over the course of a single surgical case.¿ there was no injury or impact to the patient.Further assessment found the sales representative was unable to obtain additional information.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: robin drum ; 11311 concept blvd; largo, FL 33773 ; 8653881978
• MDR Report Key: 15195137
• MDR Text Key: 305047208
• Report Number: 3007305485-2022-00125
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 10653405033837
• UDI-Public: (01)10653405033837(17)230212(10)202102125
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K120322
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 09/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/12/2023
• Device Catalogue Number: 410-2000
• Device Lot Number: 202102125
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/10/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/12/2021
• 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