Exacto 00711095Recalls & 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 00724995182564), received between Jun 15, 2023 and Apr 23, 2026 — classified as 3 malfunctions.
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.
Reports received per month
Most reported problems
Device problems
- Break1
- Detachment of Device or Device Component1
- Difficult to Open or Close1
- Insufficient Device Problem Information1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 23, 2026Break
THE USER FACILITY REPORTED THAT DURING PATIENT PROCEDURES TWO OF THEIR EXACTO COLD SNARES BROKE WHILE ATTEMPTING TO REMOVE POLYPS. THE PROCEDURES WERE COMPLETED SUCCESSFULLY FOLLOWING SHORT DELAYS USING DIFFERENT DEVICES. NO REPORT OF INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24965829 ↗MalfunctionNov 8, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
THE USER FACILITY REPORTED THAT THEIR EXACTO COLD SNARE BROKE OFF INSIDE OF THE PATIENT WHEN RETRIEVING A POLYP. THE EXACTO COLD SNARE WAS RETRIEVED WITH FORCEPS, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO REPORT OF INJURY OR PROCEDURE DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20641488 ↗MalfunctionJun 15, 2023Difficult to Open or Close; Insufficient Device Problem Information; Difficult to Open or Close; Insufficient Device Problem Information
THE USER FACILITY REPORTED THAT DURING A PATIENT PROCEDURE THEIR EXACTO COLD SNARE FAILED TO CUT A POLYP. AS A RESULT, USER FACILITY PERSONNEL HAD TO REOPEN AND DETACH THE SNARE FROM THE POLYP. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH ANOTHER SNARE. NO REPORT OF INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17140307 ↗
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.