NCIRCLE DELTA WIRE TIPLESS STONE EXTRACTOR
Received Mar 25, 2026 · Event occurred Mar 9, 2026
Report 1820334-2026-00323 · MDR key 24689152
Device
Product problems
- Loss of or Failure to Bond
- Difficult to Open or Close
Patient
Not reported
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN OR UNAVAILABLE. E1 PHONE NUMBER: (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
AS REPORTED, PRIOR TO USE FOR A TRANSURETHRAL FLEXIBLE URETEROSCOPIC LITHOTRIPSY WITH STONE EXTRACTION OF CALCULUS LOCATED IN THE UPPER SEGMENT OF THE LEFT URETER, AN NCIRCLE DELTA WIRE TIPLESS STONE EXTRACTOR WAS TESTED AND WOULD NOT OPEN. THE DEVICE DID NOT MAKE PATIENT CONTACT. A NEW BACKET WAS USED TO COMPLETE THE PROCEDURE. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES OR EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS EVENT.