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

Model Number	RLV 0045
Medical Device Problem Codes	Material Fragmentation (1261); Nonstandard Device (1420); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/02/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that an intracept curved cannula was returned for an unknown reason.A visual inspection revealed that the curved cannula handle and shaft tip were broken.The j-stylet was tested with a known good curved cannula and a known good introducer cannula.It was found that the j-stylet lacks any extreme resistance during the functional test.A product labeling review identified that the devices were used per the instructions for use (ifu) product label.A labeling review did not reveal any anomalies as it states that as with any surgical instrument, careful attention must be exercised to ensure that excessive force is not placed on the instruments or probe.Excessive force can result in product failure.A labeling review also states that in the event of inadvertent advancement of the introducer cannula during deployment of the curved cannula assembly, care must be taken to prevent potential further device damage.This can occur if mallet strikes continue to be delivered when the gear wheel is in contact with the introducer cannula.This scenario can create a condition in which the introducer cannula advances along its straight trajectory, while the curved cannula is held in the bone along its curved trajectory.This can lead to the creation of a kink in the curved cannula material.If it is suspected that this occurred, or if retraction of the curved cannula is difficult, it is recommended that introducer cannula and curved cannula be removed as a single unit, rather than retracting the curved cannula by itself.Based on all available information, there is no complaint against the functionality of the device.The investigation conclusion code for the broken curved cannula handle and shaft tip was determined to be unintended use error caused or contributed to event.The breakage of the curved cannula handle and the curved cannula shaft tip were likely due to the use of excessive force during the procedure.Lastly, it was found that the j-stylet exhibits normal functionalities.

• Brand Name: INTRACEPT
• Common Device Name: PROBE, RADIOFREQUENCY LESION
• Manufacturer (Section D): RELIEVANT MEDSYSTEMS, INC.; 1230 midas way suite 200; sunnyvale CA 94085
• Manufacturer Contact: erik sherburne ; 25155 rye canyon loop; valencia, CA 91355 ; 7632920920
• MDR Report Key: 25366973
• Report Number: 3006630150-2026-03724
• Device Sequence Number: 18638148
• Product Code: GXI
• UDI-Device Identifier: 00852454006301
• UDI-Public: 00852454006301
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K222281
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/02/2026

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 Model Number: RLV 0045
• Device Catalogue Number: RLV 0045
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/02/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/08/2026
• Initial Report FDA Received Date: 06/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown