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 Codes	Grounding Malfunction (1271); Connection Problem (2900)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/05/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Related manufacturer reference number: 2184149-2023-00093.It was reported that the during a rf procedure on (b)(6) 2023, after completing three lesions the physician received an error message stating the grounding pad detached when a probe was added for a fourth lesion.Troubleshooting was unable to resolve the issue.As such, the procedure was completed with a competitors device.
Additional Manufacturer Narrative
Based on the information provided to abbott and the investigation performed, the root cause of the field reported event could not be conclusively determined as the returned ionicrf¿ generator functioned as expected throughout investigation.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.No non-conformances associated with the reported event were identified.
Additional Manufacturer Narrative
The reported error could not be confirmed.The results of the investigation are inconclusive since the device was not returned for analysis.The device was manufactured according to specifications as supported by the receiving inspection results.Based on the information received, the cause of the reported incident could not be conclusively determined.
Additional Manufacturer Narrative
Based on information obtained, decision is not reportable as originally indicated.The procedure was completed with non-abbott generator.

• 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: 16838230
• Report Number: 3005334138-2023-00177
• Device Sequence Number: 6860805
• Product Code: GEI
• UDI-Device Identifier: 06959006303261
• UDI-Public: 06959006303261
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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,Followup,Followup
• Report Date (Section B): 11/08/2023

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: 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: 04/05/2023
• Supplement Date Received by Manufacturer: 05/25/2023; 09/18/2023; 11/08/2023
• Initial Report FDA Received Date: 04/28/2023
• Supplement Report FDA Received Date: 06/15/2023; 09/26/2023; 11/08/2023
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male
• Patient Weight: 104 KG