MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. (AF-MINNETONKA) DISPOSABLE GROUNDING PAD W/CABLE; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	RF-DGP-S
Medical Device Problem Codes	Grounding Malfunction (1271); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Partial thickness (Second Degree) Burn (2694)
Date of Event	09/23/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
During the procedure, it was reported that the patient experienced a grounding pad burn.An antibiotic ointment, gauze and tegaderm were used for treatment.
Additional Manufacturer Narrative
He reported event was for a patient burn.The results of the investigation are inconclusive since the device was not returned for analysis.However, three photographs were provided of a burn on the patients skin.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.Based on the information received, the cause of the reported incident could not be conclusively determined.

• Brand Name: DISPOSABLE GROUNDING PAD W/CABLE
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): ST. JUDE MEDICAL, INC. (AF-MINNETONKA); 14901 deveau place; minnetonka MN 55345
• Manufacturer (Section G): ST. JUDE MEDICAL, INC. (AF-MINNETONKA); 14901 deveau place; minnetonka MN 55345
• Manufacturer Contact: ronnie shalev ; 6901 preston road; plano, TX 75024 ; 9723098000
• MDR Report Key: 15697517
• Report Number: 2182269-2022-00051
• Device Sequence Number: 7300482
• Product Code: GEI
• UDI-Device Identifier: 05415067028921
• UDI-Public: 05415067028921
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K111576
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/27/2023

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: 06/04/2023
• Device Model Number: RF-DGP-S
• Device Catalogue Number: RF-DGP-S
• Device Lot Number: 20210605
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/04/2022
• Supplement Date Received by Manufacturer: 04/18/2023
• Initial Report FDA Received Date: 10/30/2022
• Supplement Report FDA Received Date: 04/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/05/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: RADIO FREQUENCY GENERATOR
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown