NCIRCLE DELTA WIRE TIPLESS STONE EXTRACTOR
Received Jun 16, 2026 · Event occurred May 20, 2026
Report 1820334-2026-00634 · MDR key 25521010
Device
Product problems
- Difficult to Open or Close
Patient
NA · Female
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
E1 - PHONE NO: (B)(6). G4 - PMA/510(K) #: EXEMPT. H3 - DEVICE EVALUATION ANTICIPATED BUT NOT YET BEGUN. THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE. THIS REPORT IS REQUIRED BY THE FDA UNDER 21 CFR PART 803. THIS REPORT IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT MADE IN IT IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED; THAT A DEATH OR SERIOUS INJURY OCCURRED; OR THAT ANY COOK DEVICE CAUSED OR CONTRIBUTED TO; OR IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF A MALFUNCTION OCCURRED.
Description of Event or Problem
IT WAS REPORTED THAT THE NCIRCLE DELTA WIRE TIPLESS STONE EXTRACTOR WOULD NOT OPEN DURING A TRANSURETERAL SOFT ENDOSCOPY LITHOTRIPSY AND RETROGRADE INTRARENAL SURGERY (RIRS) STONE REMOVAL PROCEDURE. THE BASKET CLOSURE TEST WAS PERFORMED BEFORE USE, WHICH WAS NORMAL. AFTER ABOUT 2 STONE EXTRACTIONS, THE BASKET FAILED TO OPEN. THE USER CHANGED TO A NEW BASKET TO COMPLETE THE PROCEDURE. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE.