Exacto 00711094Recalls & reported problems
US Endoscopy · The Exacto cold snare is intended to be used without diathermic energy for the endoscopic resection of polyp tissue in the gastrointestinal tract. · Class 1
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00724995182557), received between Dec 1, 2022 and Feb 12, 2026 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (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.
Reports received per month
Most reported problems
Device problems
- Detachment of Device or Device Component1
- Difficult to Remove1
- Failure to Cut1
- Mechanical Problem1
Patient problems
- Foreign Body In Patient1
- Laceration(s)1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 12, 2026Mechanical Problem
THE USER FACILITY REPORTED VIA VIGILANCE REPORT THAT DURING A PATIENT PROCEDURE, THE PATIENT EXPERIENCED A CUT WITH THE USE OF AN EXACTO COLD SNARE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO REPORT OF INJURY.
Patient problems: Laceration(s)
MAUDE report 24328882 ↗MalfunctionFeb 12, 2026Difficult to Remove; Failure to Cut
THE USER FACILITY REPORTED THAT DURING A PATIENT PROCEDURE THEIR EXACTO COLD SNARE WOULD NOT CUT THROUGH A POLYP AND BECAME STUCK. USER FACILITY PERSONNEL CUT THE HANDLE OF THE SNARE TO REMOVE THE SCOPE AND THE PATIENT WAS TRANSFERRED TO ANOTHER FACILITY TO HAVE THE SNARE WIRE REMOVED. THE PATIENT WAS DISCHARGED THE NEXT DAY.
Patient problems: Foreign Body In Patient
MAUDE report 24328344 ↗MalfunctionDec 1, 2022Detachment of Device or Device Component; Detachment of Device or Device Component
THE USER FACILITY REPORTED THAT DURING A PROCEDURE INVOLVING AN EXACTO COLD SNARE, THE SNARE LOOP DETACHED FROM THE DRIVE CABLE. THE SNARE WAS RETRIEVED, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO REPORT OF INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15893842 ↗
Other SNARE, NON-ELECTRICAL devices
- Captivator™ COLD M00561100Boston Scientific Corporation · SNARE, NON-ELECTRICAL377 reports
- CAPTIVATOR II M00561220Boston Scientific Corporation · SNARE, NON-ELECTRICAL1 recall150 reports
- Single Use Electrosurgical Snare SD-400 SD-400U-10Olympus Medical Systems Corp. · SNARE, NON-ELECTRICAL1 recall13 reports
- Single Use Electrosurgical Snare SD-400 SD-400U-15Olympus Medical Systems Corp. · SNARE, NON-ELECTRICAL1 recall7 reports
- M-Catch 1175-01Diversatek Healthcare, Inc. · Snare, Non-Electrical1 recall0 reports
- Exacto 00711115US Endoscopy · SNARE, NON-ELECTRICAL35 reports
- CAPTIVATOR II M00561240Boston Scientific Corporation · SNARE, NON-ELECTRICAL26 reports
- Single Use Electrosurgical Snare SD-400 SD-400-10Olympus Medical Systems Corp. · SNARE, NON-ELECTRICAL16 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.