OPTIMIZER 000476Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10653405053408), received between Aug 16, 2016 and Oct 25, 2023 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Break” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryOct 25, 2023Failure to Cut; Failure to Cut

  THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER, THAT THE 000476, OPT SNR SM FIRM OVAL-OLY 10/CS WAS BEING USED DURING A COLONOSCOPY PROCEDURE ON (B)(6) 2023 WHEN IT WAS REPORTED ¿ THE SNARE DID NOT PROPERLY CUT THE TISSUE OF A POLYP DURING A POLYPECTOMY PROCEDURE. THE PHYSICIAN WANTED A HOT SNARE AND THE SNARE CAUSED EXCESS BLEEDING IN THE PATIENT.¿ THE PROCEDURE WAS COMPLETED WITH THE SAME ALTERNATE DEVICE AND A 10-MINUTE DELAY WAS REPORTED. SURGICAL INTERVENTION WAS REPORTED AS ¿HEMOSTASIS WITH THE TIP OF THE SNARE TO STOP THE BLEEDING.¿ THERE WAS NO REPORT OF EXTENDED HOSPITALIZATION TO THE PATIENT OR USER. THE CURRENT STATUS OF THE PATIENT WAS REPORTED AS ¿OVERALL THE PATIENT IS FINE.¿ THIS REPORT IS BEING RAISED ON REPORTED INJURY DUE TO THE PATIENT EXPERIENCING EXCESSIVE BLEEDING.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 18005514 ↗
• MalfunctionAug 16, 2016Break

  THE END USER FACILITY REPORTED THAT DURING USE OF A CONMED OPTIMIZER POLYPECTOMY SNARE IN A COLONOSCOPY PROCEDURE AND WHILE REMOVING THE POLYP, THE "SMALL SNARE FELL APART DURING THE PROCEDURE". FOLLOW-UP WITH THE USER FACILITY CONFIRMED THAT THE BROKEN PIECES WERE RETRIEVED WITH NO PROBLEMS NOTED. USING ANOTHER SNARE, THE PROCEDURE WAS OTHERWISE COMPLETED WITH NO FURTHER COMPLICATIONS OR PATIENT INJURY. THIS REPORT IS RAISED ON THE BASIS OF POTENTIAL INJURY WITH RECURRENCE. DUE TO PRODUCT CONTAMINATION, THE USED/DAMAGED DEVICE IS NOT BEING RETURNED TO THE MANUFACTURE FOR EVALUATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5878174 ↗