MAUDE Adverse Event Report: RELIEVANT MEDSYSTEMS INTRACEPT; PROBE, RADIOFREQUENCY LESION

Model Number	FG0060
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/26/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an intracept procedure the physician encountered hard bone and while malleting caused the peek material of the curved cannula to shear off into the patient.Based on the available information, bsc could not confirm the location of the device fragment.The procedure was completed without further incident.

• Brand Name: INTRACEPT
• Common Device Name: PROBE, RADIOFREQUENCY LESION
• Manufacturer (Section D): RELIEVANT MEDSYSTEMS; 1230 midas way; suite 200; sunnyvale CA 94085 4068
• Manufacturer (Section G): RELIEVANT MEDSYSTEMS, INC.; 7201 metro blvd.; ste 300; edina MN 55439
• Manufacturer Contact: erik sherburne ; 25155 rye canyon loop; valencia, CA 91355 ; 7632920920
• MDR Report Key: 21364971
• Report Number: 3006789852-2025-00001
• Device Sequence Number: 8416447
• Product Code: GXI
• UDI-Device Identifier: 00852454006189
• UDI-Public: 00852454006189
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K170827
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/12/2025

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: 02/10/2025
• Device Model Number: FG0060
• Device Catalogue Number: FG0060
• Device Lot Number: 127304123
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/13/2025
• Initial Report FDA Received Date: 02/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/10/2023
• 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