MAUDE Adverse Event Report: ABBOTT MEDICAL (SH-PLYMOUTH) DISPOSABLE SIMPLICITY ELECTRODE; RFA GENERATOR

Model Number	RFDE-SI
Medical Device Problem Code	Insufficient Heating (1287)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/05/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported during a procedure the generator indicated an error that the temperature was rising too slowly.The case was abandoned with no consequences to the patient.
Additional Manufacturer Narrative
E1 reporter phone number: (b)(6).
Additional Manufacturer Narrative
An event of a temperature error message was reported.One video was submitted to product performance engineering, no product was received.The returned video appeared to show an ionic generator with a temperature error message.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 SIMPLICITY ELECTRODE
• Common Device Name: RFA GENERATOR
• Manufacturer (Section D): ABBOTT MEDICAL (SH-PLYMOUTH); 5050 nathan lane north; plymouth MN 55442
• Manufacturer (Section G): ABBOTT MEDICAL (SH-PLYMOUTH); 5050 nathan lane north; plymouth MN 55442
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 18091054
• Report Number: 3005334138-2023-00491
• Device Sequence Number: 12429787
• Product Code: GXI
• UDI-Device Identifier: 05415067028976
• UDI-Public: 05415067028976
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K011387
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/01/2023

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2023
• Device Model Number: RFDE-SI
• Device Lot Number: 7690032
• 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: 10/17/2023
• Supplement Date Received by Manufacturer: 12/01/2023
• Initial Report FDA Received Date: 11/08/2023
• Supplement Report FDA Received Date: 12/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/12/2020
• 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 Age: 57 YR
• Patient Sex: Female