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

Catalog Number	CRA-SGP
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	11/22/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
A distributor reported on behalf of a customer that the cra-sgp, avanos, dispersive electrode, thermogard, adult, dual foil device was used in a procedure on approximately (b)(6) 2023, when the ¿grounding pad became loose and left a burn on the customer¿s calf where the pad was placed.¿.Additional information indicated that ¿patient was seen for a coolief rftc of the geniculate nerves.Patient returned to the clinic, same day, with complaints of a burn to her calf where the grounding pad was placed.Grounding pad was not visible during the procedure.At the end of the procedure when the technician went to remove the pad it was noted to be loose.Calf placed horizontally¿.Er visit, burn treated with silvadene.Follow up with plastic surgery.¿.A good faith effort was made to obtain further information but no response has been received to date.This report is being raised due to the reported injury of a burn of unknown degree to the patient.
Additional 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.We will continue to monitor for trends through the complaint system to assure patient safety.
Additional 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 this is the only such occurrence for this lot number and failure mode.(b)(4).We will continue to monitor for trends through the complaint system to assure patient safety.
Event or Problem Description
A distributor reported on behalf of a customer that the cra-sgp, avanos, dispersive electrode, thermogard, adult, dual foil device was used in a procedure on approximately (b)(6) 2023, when the "grounding pad became loose and left a burn on the customer¿s calf where the pad was placed." additional information indicated that "patient was seen for a coolief rftc of the geniculate nerves.Patient returned to the clinic, same day, with complaints of a burn to her calf where the grounding pad was placed.Grounding pad was not visible during the procedure.At the end of the procedure when the technician went to remove the pad it was noted to be loose.Calf placed horizontally¿er visit, burn treated with silvadene.Follow up with plastic surgery." a good faith effort was made to obtain further information but no response has been received to date.This report is being raised due to the reported injury of a burn of unknown degree to the patient.

• Brand Name: AVANOS, DISPERSIVE ELECTRODE, THERMOGARD, ADULT, DUAL FOIL
• Common Device Name: 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: beth madeline ; 11311 concept blvd; largo, FL 33773 ; 7274708358
• MDR Report Key: 18411116
• Report Number: 1320894-2023-00277
• Device Sequence Number: 2932928
• Product Code: GEI
• UDI-Device Identifier: 20653405986581
• UDI-Public: (01)20653405986581(17)250112(10)202301131
• Combination Product (Y/N): N
• Initial Reporter State: MS
• Initial Reporter Country: US
• PMA/510(K) Number: K140658
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 01/23/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 01/12/2025
• Device Catalogue Number: CRA-SGP
• Device Lot Number: 202301131
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/07/2023
• Supplement Date Received by Manufacturer: 01/19/2024
• Initial Report FDA Received Date: 12/28/2023
• Supplement Report FDA Received Date: 01/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/13/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 74 YR
• Patient Sex: Female
• Patient Weight: 60 KG
• Patient Ethnicity: Non Hispanic