MAUDE Adverse Event Report: ABBOTT MEDICAL (SH-PLYMOUTH) STAINLESS STEEL ELECTRODE, DISPOSABLE, 10CM; PROBE, RADIOFREQUENCY LESION

Model Number	RFDE-10
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/12/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Reporter phone number: (b)(6).Reporter fax number: (b)(6).
Event or Problem Description
It was reported that during device preparation for a procedure, a hair was noted inside the package.As such, a replacement device was used to complete the procedure.
Additional Manufacturer Narrative
The reported foreign material was confirmed.A hair was noted inside the returned pouch.The original sterile packaging had been opened prior to receipt of the device.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the foreign material remains unknown.

• Brand Name: STAINLESS STEEL ELECTRODE, DISPOSABLE, 10CM
• Common Device Name: PROBE, RADIOFREQUENCY LESION
• 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: 18619430
• Report Number: 3005334138-2024-00037
• Device Sequence Number: 2466247
• Product Code: GXI
• UDI-Device Identifier: 05415067029027
• UDI-Public: 05415067029027
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 03/25/2024

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: 02/28/2026
• Device Model Number: RFDE-10
• Device Lot Number: 8950957
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 01/12/2024
• Supplement Date Received by Manufacturer: 03/15/2024
• Initial Report FDA Received Date: 01/31/2024
• Supplement Report FDA Received Date: 03/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/20/2023
• 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