MAUDE Adverse Event Report: CONMED UTICA AVANOS, DISPERSIVE ELECTRODE, THERMOGARD, ADULT, DUAL FOIL; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number CRA-SGP

Device Problem Device Dislodged or Dislocated (2923)

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

Event Type  malfunction  

Event Description

The customer reported that the device, cra-sgp, avanos, dispersive electrode, thermogard, adult, dual foil, was being used during an unknown procedure on an unknown date when it was reported ¿we have been having continuing issues with our rf grounding pads, when we put them on the patient an alert comes up saying poor skin contact or grounding pad not connected.We always make sure this patient's skin is dry, not oily, or hairy.We end up having to unplug then replug the grounding pad back in, sometimes multiple times.We have not had any patient injury.We have three pads attempted to the use on one patient.¿.There was no report of injury, medical intervention, or hospitalization for the patient.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.

Manufacturer Narrative

The device was not returned for evaluation to date 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 20 complaints, regarding 30 devices, for this device family and failure mode.During this same time frame 1,756,040 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 0.00002.Per the instructions for use, the user is advised to always use largest size pad per the 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.This issue will continue to be monitored through the complaint system to assure patient safety.

• Brand Name: AVANOS, DISPERSIVE ELECTRODE, THERMOGARD, ADULT, DUAL FOIL
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): CONMED UTICA; 525 french rd; utica NY 13502
• Manufacturer (Section G): CONMED UTICA; 525 french rd; utica NY 13502
• Manufacturer Contact: john berga ; 11311 concept blvd; largo, FL 33773 ; 7273995358
• MDR Report Key: 15181916
• MDR Text Key: 297994243
• Report Number: 1320894-2022-00170
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 20653405986581
• UDI-Public: (01)20653405986581(17)240209(10)202202091
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K140658
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 08/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/09/2024
• Device Model Number: CRA-SGP
• Device Catalogue Number: CRA-SGP
• Device Lot Number: 202202091
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/03/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/09/2022
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1
• Patient Ethnicity: Non Hispanic