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

Model Number CRA-SGP

Device Problems Expiration Date Error (2528); Device Dislodged or Dislocated (2923)

Patient Problem Partial thickness (Second Degree) Burn (2694)

Event Date 02/01/2022

Event Type  Injury  

Manufacturer Narrative

This mdr is being submitted as an update to mdr (b)(4).The reporter updated the device catalog information which changed the registration number of the device for the manufacturing location.This initial is submitted as the follow up with updated and complete information.Manufacturing narrative: the device is not being returned and no photograph evidence was provided.Therefore, the reported failure could not 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.Based on the device history record the device expired on september 16, 2021.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 14 complaints, regarding 15 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 0.000001.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.This issue will continue to be monitored through the complaint system to assure patient safety.

Event Description

The distributor reported on behalf of their customer that the cra-sgp, avanos, dispersive electrode, was being used during a left l4, 5, sa facet radio frequency ablation procedure on (b)(6) 2022 when it was reported ¿patient resulted in 2nd degree burn on leg from grounding pad.Patient mentioned pain during procedure that sounded similar to usual complaints, presented to clinic today (3-4 days later) with burn.¿ there was no report of medical intervention or hospitalization for the patient.Further information received found that the expiration date had expired, and the device had been used without checking the expiration date.And when the equipment wasn¿t getting the right impedance and temperature, the clinicians decided to switch to a different generator and went to remove the pad and it slid off the leg as if it had not entirely adhered.The patient had a relatively hairy leg and was perspiring slightly but nothing out of the ordinary per the clinicians.The clinicians did not assess the leg between switching generators as the patient was covered by a sterile drape.The pain generator impedance was around 1000 and the temperature would not go above 40 degrees.The burn was approximately 2.5-inches by 1-inch on skin with slight blistering.At the time of assessment the burn was healing well, no signs or symptom of infection.Again, this was noted 3-4 days later, there was no indication at the time of procedure the patient had sustained an injury, the clinicians thought they just had an equipment malfunction.This report is being raised on the basis of injury due to patient sustaining a 2nd degree burn.Update: as of notification (b)(6) 2022, patient status, burn became substantially worse over the following week after the event occurred.Patient is now being treated at the burn center.Update: as of notification 27jun22, the device has been updated from pma-gp-bay, ground pad to cra-sgp, avanos, dispersive electrode, thermogard, adult.

• 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: 15192555
• MDR Text Key: 297528317
• Report Number: 1320894-2022-00172
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 20653405986581
• UDI-Public: (01)20653405986581(17)210916(10)201909171
• 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: Other,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 08/09/2022

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?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/16/2021
• Device Model Number: CRA-SGP
• Device Catalogue Number: CRA-SGP
• Device Lot Number: 201909171
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/02/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/17/2019
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 44 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic