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

Model Number	RLV 0075
Medical Device Problem Codes	Material Fragmentation (1261); Nonstandard Device (1420)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	10/08/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a curved cannula was returned for an unknown reason and analyzed.It was found that the curved cannula shaft tips were sheared.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.It is unknown whether any device fragments were left behind inside the patient.
Event or Problem Description
It was reported that a curved cannula was returned for an unknown reason and analyzed.It was found that the curved cannula shaft tips were sheared.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.It is unknown whether any device fragments were left behind inside the patient.
Event or Problem Description
It was reported that a curved cannula was returned for an unknown reason and analyzed.It was found that the curved cannula shaft tips were sheared.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.It is unknown whether any device fragments were left behind inside the patient.
Additional Manufacturer Narrative
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.A risk review was completed and confirmed that the event of sheared peek - distal tip was defined in the risk documentation.This event type has been accounted for during product risk analysis to support acceptable risk benefit for the product.Based on limited information, the reported event of the curved cannula sheared peek and possible unretrieved device fragments was unable to be confirmed as the device was returned for an unknown reason and no further information could be obtained.Therefore, the probable cause is unintended use error caused or contributed to event.The shearing found in the visual inspection was likely due to the use of excessive force during the procedure.

• Brand Name: INTRACEPT
• Common Device Name: PROBE, RADIOFREQUENCY LESION
• Manufacturer (Section D): RELIEVANT MEDSYSTEMS, INC.; 1230 midas way suite 200; sunnyvale CA 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: 23931465
• Report Number: 3006630150-2025-11797
• Device Sequence Number: 14855776
• Product Code: GXI
• UDI-Device Identifier: 00852454006257
• UDI-Public: (01)00852454006257(17)260610(10)743281
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 05/26/2026

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 Expiration Date: 06/10/2026
• Device Model Number: RLV 0075
• Device Catalogue Number: RLV 0075
• Device Lot Number: 743281
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/08/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/01/2025
• Supplement Date Received by Manufacturer: 12/31/2025; 02/27/2026; 04/27/2026
• Initial Report FDA Received Date: 12/30/2025
• Supplement Report FDA Received Date: 01/29/2026; 03/30/2026; 05/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/11/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown