INTRACEPT
Received Jul 2, 2026 · Event occurred Jun 3, 2026
Report 3006630150-2026-04584 · MDR key 25698424
Device
Generic name
Probe, Radiofrequency Lesion
Manufacturer
Relievant Medsystems, Inc.Model number
RLV 0065Catalog number
RLV 0065
Lot number
39388267
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
Not reported
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THAT DURING AN INTRACEPT PROCEDURE, THE SCRUB TECHNICIAN INSERTED THE DIAMOND STYLET INTO THE INTRODUCER CANNULA. SHE GRABBED THE DIAMOND STYLET AND BEVEL STYLET FROM THE MAYO STAND AND PUT THEM ON THE BACK TABLE. WHILE DOING SO, BOTH STYLETS POKED A HOLE IN THE STERILE DRAPE ON THE BACK TABLE. BOTH THE SCRUB TECHNICIAN AND CIRCULATING NURSE CHECKED THE TABLE AND CONFIRMED IT POKED THROUGH. A NEW INTRACEPT KIT WAS OPENED TO MINIMIZE INFECTION RISK. THE PROCEDURE WAS COMPLETED AS SCHEDULED. THERE WERE NO DEVICE ISSUES AND NO PATIENT COMPLICATIONS. THE PATIENT IS EXPECTED TO FULLY RECOVER. ALL DEVICES WERE DISCARDED AND WILL NOT BE RETURNED FOR ANALYSIS.