NCIRCLE DELTA WIRE TIPLESS STONE EXTRACTOR
Received Mar 31, 2026 · Event occurred Mar 17, 2026
Report 1820334-2026-00352 · MDR key 24750254
Device
Product problems
- Difficult to Open or Close
Patient
Female
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THAT THE OPEN AND CLOSE FUNCTION ON THE HANDLE OF AN NCIRCLE DELTA WIRE TIPLESS STONE EXTRACTOR DID NOT WORK DURING AN UNKNOWN PROCEDURE. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE.
Additional Manufacturer Narrative
G4 - PMA/510(K) #: EXEMPT H3 ¿ THE DEVICE IS NOT BEING RETURNED FOR EVALUATION. 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.