INTRACEPT
Report
- Report Number
- 3006630150-2025-11797
- Event Type
- Malfunction
- Date Received
- December 30, 2025
- Date of Event
- October 8, 2025
- Report Date
- May 26, 2026
- Manufacturer
- RELIEVANT MEDSYSTEMS, INC.
- Product Code
- GXI
- UDI-DI
- 00852454006257
- PMA / PMN Number
- K222281
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
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.
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.
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.
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.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 246196 | INTRACEPT | PROBE, RADIOFREQUENCY LESION | GXI | RELIEVANT MEDSYSTEMS, INC. | RLV 0075 | 743281 | 00852454006257 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |