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 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 during a c-section surgery and the ¿bovie grounding pad would not stick to patient brand new out of the package.This has happened twice this week in ob and many other times in the past as well as patients in the or¿.There was no report of injury, medical intervention or prolonged hospitalization for the patient.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.

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.

Manufacturer Narrative

The device will not be returned, and no photographic evidence was provided.Therefore, the reported event 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 a total of 6 complaints for this lot number and failure mode.(b)(4).Per the instructions for use, the user is advised the following: 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.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.We will continue to monitor for trends 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 cable, 100/case was being used during a c-section surgery and the ¿bovie grounding pad would not stick to patient brand new out of the package.This has happened twice this week in ob and many other times in the past as well as patients in the or¿.There was no report of injury, medical intervention or prolonged hospitalization for the patient.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: 16404773
• MDR Text Key: 309954190
• Report Number: 3007305485-2023-00038
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 10653405033837
• UDI-Public: (01)10653405033837(17)240314(10)202203155
• 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,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 03/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/14/2024
• Device Catalogue Number: 410-2000
• Device Lot Number: 202203155
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/08/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/15/2022
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1
• Patient Ethnicity: Non Hispanic