MAUDE Adverse Event Report: ST. JUDE MEDICAL (AFD-PLYMOUTH) IONIC RF¿ CATHAY BRANDED GROUNDING PAD; ELECTROSURGICAL CUTTING AND COAGULATION DEVICE AND ACCESSORIES

Model Number	GP202D-AC
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/10/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Related manufacturer report number: 3005334138-2023-00151, 3005334138-2023-00152.It was reported that during a procedure, a grounding error message appeared on an rfa generator.Troubleshooting revealed a connection problem with the grounding pad plug and the generator.As a result, the procedure could not be completed.
Additional Manufacturer Narrative
An event of a loose grounding pad connector and error was reported.No devices were received in lab for analysis.The device was manufactured according to specifications as supported by the receiving inspection results.A capa exists related to this complaint investigation.

• Brand Name: IONIC RF¿ CATHAY BRANDED GROUNDING PAD
• Common Device Name: ELECTROSURGICAL CUTTING AND COAGULATION DEVICE AND ACCESSORIES
• Manufacturer (Section D): ST. JUDE MEDICAL (AFD-PLYMOUTH); 5050 nathan lane north; plymouth MN 55442
• Manufacturer (Section G): ST. JUDE MEDICAL (AFD-PLYMOUTH); 5050 nathan lane north; plymouth MN 55442
• Manufacturer Contact: ronnie shalev ; 6901 preston road; plano, TX 75024 ; 9723098000
• MDR Report Key: 16716496
• Report Number: 3005334138-2023-00150
• Device Sequence Number: 7274866
• Product Code: GEI
• UDI-Device Identifier: 06959006303261
• UDI-Public: 06959006303261
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K993306
• 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): 09/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/27/2024
• Device Model Number: GP202D-AC
• Device Lot Number: 221200401
• 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: 03/13/2023
• Supplement Date Received by Manufacturer: 09/05/2023
• Initial Report FDA Received Date: 04/11/2023
• Supplement Report FDA Received Date: 09/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/28/2022
• 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
• Patient Sex: Unknown