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

Model Number	RLV 0015
Medical Device Problem Codes	Disconnection (1171); Impedance Problem (2950); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/07/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a procedure, the probe had an error code 25 and an impedance error during the first burn.No levels were completed prior to the probe errors occurring and the patient was sedated with monitored anesthesia care (mac) anesthesia.When the physician removed the probe and tried to reconnect it to the generator, the error code 25 appeared on the generator display and there appeared to be a disconnection from the electrode in the probe.The physician removed the whole system and the probe was fully intact with no signs of damage to the sheath.After an unsuccessful attempt to dock at l5, the physician decided to abort the procedure.
Event or Problem Description
It was reported that during a procedure, the probe had an error code 25 and an impedance error during the first burn.No levels were completed prior to the probe errors occurring and the patient was sedated with monitored anesthesia care (mac) anesthesia.When the physician removed the probe and tried to reconnect it to the generator, the error code 25 appeared on the generator display and there appeared to be a disconnection from the electrode in the probe.The physician removed the whole system and the probe was fully intact with no signs of damage to the sheath.After an unsuccessful attempt to dock at l5, the physician decided to abort the procedure.
Event or Problem Description
It was reported that during a procedure, the probe had an error code 25 and an impedance error during the first burn.No levels were completed prior to the probe errors occurring and the patient was sedated with monitored anesthesia care (mac) anesthesia.When the physician removed the probe and tried to reconnect it to the generator, the error code 25 appeared on the generator display and there appeared to be a disconnection from the electrode in the probe.The physician removed the whole system and the probe was fully intact with no signs of damage to the sheath.After an unsuccessful attempt to dock at l5, the physician decided to abort the procedure.
Additional Manufacturer Narrative
The returned probe was analyzed and the event of the probe exhibiting an error code 25 and disconnection issue was confirmed.The probe placement was not detected when connected into the generator.The ring electrode passed the continuity test, but the tip electrode failed the continuity test.X-ray inspection revealed one of the thermocouple wires broken at the terminator and the stainless-steel terminator was disconnected from its interconnect pin within the hub.

• Brand Name: INTRACEPT RF PROBE
• Common Device Name: PROBE, RADIOFREQUENCY LESION
• Manufacturer (Section D): RELIEVANT MEDSYSTEMS, INC.; 1230 midas way suite 200; sunnyvale 94085
• Manufacturer (Section G): RELIEVANT MEDSYSTEMS, INC.; 7201 metro blvd ste 300,; mn 55439; edina MN 55439
• Manufacturer Contact: erik sherburne ; 25155 rye canyon loop; valencia, CA 91355 ; 7632920920
• MDR Report Key: 21757455
• Report Number: 3006630150-2025-02082
• Device Sequence Number: 15503939
• Product Code: GXI
• UDI-Device Identifier: 00852454006219
• UDI-Public: 00852454006219
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K180369
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/11/2025

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: 08/16/2026
• Device Model Number: RLV 0015
• Device Catalogue Number: RLV 0015
• Device Lot Number: 109168857
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/07/2025
• Supplement Date Received by Manufacturer: 04/04/2025; 05/15/2025
• Initial Report FDA Received Date: 04/02/2025
• Supplement Report FDA Received Date: 04/29/2025; 06/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/16/2024
• 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: Required Intervention
• Patient Age: 63 YR
• Patient Sex: Male