NCIRCLE DELTA WIRE TIPLESS STONE EXTRACTOR
Received Jul 2, 2026 · Event occurred Jun 9, 2026
Report 1820334-2026-00704 · MDR key 25689957
Device
Product problems
- Break
Patient
Not reported
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED DURING A LEFT URETEROSCOPY LITHOTRIPSY PROCEDURE THE NCIRCLE DELTA WIRE TIPLESS STONE EXTRACTOR WAS UNABLE TO OPEN AND CLOSE. THE PROCEDURE WAS COMPLETED THROUGH OPENING ANOTHER BASKET. A PRELIMINARY REVIEW OF THE RETURNED DEVICE APPEARS TO SHOW THE SUPPORT TUBING AND BASKET SHEATH WERE BROKEN NEAR THE HANDLE. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE.
Additional Manufacturer Narrative
E1 - PHONE NUMBER: (B)(6) G4 - PMA/510(K) #: EXEMPT H3 - DEVICE HAS BEEN RETURNED AND PRELIMINARY EVALUATION HAS BEEN PERFORMED, HOWEVER, OUR INVESTIGATION IS ONGOING AND DEVICE EVALUATION SUMMARY WILL BE INCLUDED IN OUR FOLLOW UP REPORT ONCE OUR INVESTIGATION HAS BEEN COMPLETED. 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.