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 Problems Detachment of Device or Device Component (2907); Device Dislodged or Dislocated (2923)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/28/2023

Event Type  malfunction  

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.

Event Description

The customer reported that the device, 410-2000, cga, surefit ground pad with 10ft cable, was being used during an unnamed surgical procedure on (b)(6) 2023 and that ¿the bovie pad does not stick and does not register with the bovie machine¿.Further assessment revealed that the patient site had been prepped "per rn's follow proper protocol" and was dry at the time the pad was introduced.It was further reported that there were no folds in the device, and the patient was not injured.There was a delay of five minutes, and the surgery was completed with a covidien bovie pad.There was no report of medical intervention or hospitalization for this event.This report is being raised due to the reported malfunction with potential for injury upon reoccurrence.

Manufacturer Narrative

The reported event of ¿does not stick¿ was confirmed.There were no obvious signs of abnormalities or defects upon visual inspection.Upon functional inspection, the pads do not stay adhered to the skin.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 such occurrence for this lot number and failure mode.(b)(4).Per the instructions for use, the user is advised to: 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 customer reported that the device, 410-2000, cga, surefit ground pad with 10ft cabel, was being used during an unnamed surgical procedure on (b)(6) 2023 and that ¿the bovie pad does not stick and does not register with the bovie machine¿.Further assessment revealed that the patient site had been prepped "per rn's follow proper protocol" and was dry at the time the pad was introduced.It was further reported that there were no folds in the device, and the patient was not injured.There was a delay of five minutes, and the surgery was completed with a covidien bovie pad.There was no report of medical intervention or hospitalization for this event.This report is being raised due to the reported 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: beth madeline ; 11311 concept blvd; largo, FL 33773 ; 7274708358
• MDR Report Key: 17886598
• MDR Text Key: 325718738
• Report Number: 3007305485-2023-00213
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 10653405033837
• UDI-Public: (01)10653405033837(17)240822(10)202208236
• 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
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date: 11/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/06/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 410-2000
• Device Lot Number: 202208236
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Manufacturer Received: 11/16/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/23/2022
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1
• Patient Ethnicity: Non Hispanic