Exacto 00711115Recalls & 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
Quick summary
The Exacto cold snare is a non-electric wire loop from US Endoscopy used to cut out polyp tissue during endoscopy. Its 34 reports mostly describe the snare breaking, failing to open or close, or coming apart in the user's hand mid-procedure. Reports also mention a perforation and a laceration; there was 1 injury and no deaths. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 35
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 35 adverse event reports that list this exact device (DI 00724995182618), received between Dec 28, 2020 and Sep 9, 2026 — classified as 1 injury, 34 malfunctions.
The most frequently reported specific device problem is “Break” (11 reports).
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
- Break11
- Insufficient Device Problem Information8
- Detachment of Device or Device Component4
- Difficult to Open or Close4
- Activation Problem3
- Device Difficult to Setup or Prepare2
- Adverse Event Without Identified Device or Use Problem1
- Device Handling Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions30
- Insufficient Information2
- Hematoma1
- Laceration(s)1
- Perforation1
Recent adverse event reports
The 25 most recent of 35 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 9, 2026Insufficient Device Problem Information
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50701749 ↗InjuryAug 28, 2026Insufficient Device Problem Information
The user facility reported via Vigilance Report during a patient procedure, the inner wire of the Exacto Cold Snare broke when cutting a polyp. Another snare was used to successfully complete the procedure. No report of injury.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50497738 ↗MalfunctionMay 28, 2026Device Difficult to Setup or Prepare
THE USER FACILITY REPORTED VIA VIGILANCE REPORT FROM HEALTH CANADA THAT DURING A PATIENT PROCEDURE AN EXACTO COLD SNARE WAS "USED ON A PATIENT TO OBTAIN A POLYP IN THE ASCENDING AREA OF THE COLON. IT WAS SUCCESSFULLY REMOVED. WHEN THE PHYSICIAN WANTED TO REMOVE ANOTHER POLYP AT THE TRANSVERSE AREA THE SNARE OPENED UP BUT COULD NOT CUT OF THE POLYP. A SECOND SNARE WAS USED AND REMOVED WITH OUT ANY CONCERNS."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25319494 ↗MalfunctionMay 15, 2026Device Difficult to Setup or Prepare
THE USER FACILITY REPORTED VIA MEDWATCH #(B)(4) "COLD SNARE REQUESTED BY PHYSICIAN AND PLACED IN SCOPE. SNARE WOULD NOT OPEN, REMOVED FROM SCOPE. NEW SNARE OBTAINED AND CASE CONTINUED WITH NO FURTHER ISSUES. SCOPE GIVEN TO VENDOR REP.". NO REPORT OF INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25183340 ↗MalfunctionMay 6, 2026Break
THE USER FACILITY REPORTED VIA VIGILANCE REPORT (B)(4) THAT DURING A PATIENT PROCEDURE THE HANDPIECE TO THEIR EXACTO COLD SNARE "FELL APART" IN THE USERS HAND AND WIRES BECAME EXPOSED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY UTILIZING ANOTHER DEVICE. NO REPORT OF INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25095874 ↗MalfunctionOct 31, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE USER FACILITY REPORTED THAT DURING A PATIENT PROCEDURE, THE PATIENT EXPERIENCED A PERFORATION WITH THE USE OF AN EXACTO COLD SNARE. THE USER FACILITY DID NOT DISCLOSE WHETHER ADDITIONAL MEDICAL TREATMENT WAS REQUIRED.
Patient problems: Perforation
MAUDE report 23438914 ↗MalfunctionApr 17, 2025Improper or Incorrect Procedure or Method; Insufficient Device Problem Information; Improper or Incorrect Procedure or Method; Insufficient Device Problem Information
THE USER FACILITY REPORTED VIA MEDWATCH#: (B)(4) THAT THEIR "EXACTO COLD SNARE WOULD NOT COMPLETELY COME OUT OF THE DEVICE." NO REPORT OF INJURY OR PROCEDURE DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21861941 ↗MalfunctionMar 21, 2025Break; Break
THE USER FACILITY REPORTED THAT DURING A PATIENT PROCEDURE THEIR EXACTO COLD SNARE BROKE WHEN CLOSED. THERE WAS A REPORT OF INJURY, HOWEVER IT IS UNKNOWN WHAT TYPE OF INJURY WAS SUSTAINED. DETAILS ON THE OUTCOME OF THE PROCEDURE OR STATUS OF THE PATIENT WERE NOT PROVIDED.
Patient problems: Insufficient Information
MAUDE report 21663504 ↗MalfunctionMar 18, 2025
EXACTO COLD SNARE WOULD NOT COMPLETELY COME OUT OF THE DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21630663 ↗MalfunctionNov 20, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
THE USER FACILITY REPORTED THAT DURING A COLONOSCOPY, THEIR EXACTO COLD SNARE WAS PLACED AROUND A LARGE POLYP AND BROKE. THE LENGTH OF WIRE REMAINING WAS REMOVED WITH BIOPSY FORCEPS WHILE THE POLYP WAS RETRIEVED WITH ANOTHER DEVICE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO REPORT OF INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20736841 ↗MalfunctionAug 9, 2024Difficult to Open or Close; Difficult to Open or Close
THE USER FACILITY REPORTED VIA VIGILANCE REPORT TO ANSM THAT DURING A PATIENT PROCEDURE THEIR EXACTO COLD SNARE UNFOLDS A QUARTER OF THE WAY INSIDE AND OUTSIDE THE ENDOSCOPE. THE USER FACILITY USED ANOTHER EXACTO COLD SNARE, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19951448 ↗MalfunctionJul 26, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
THE USER FACILITY REPORTED THAT DURING A COLONOSCOPY THE WIRE TO THEIR EXACTO COLD SNARE BROKE INSIDE THE PATIENT AND CAME OFF THE DEVICE. THE WIRE WAS RECOVERED WITH BIOPSY FORCEPS. NO REPORT OF INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19841235 ↗MalfunctionJul 18, 2024Detachment of Device or Device Component; Insufficient Device Problem Information; Detachment of Device or Device Component; Insufficient Device Problem Information
THE DISTRIBUTOR REPORTED THAT THE SNARE FELL OFF DURING A POLYP REMOVAL AND HAD TO BE RETRIEVED WITH AN ADDITIONAL SNARE. NO REPORT OF INJURY. PROCEDURE COMPLETED UTILIZING ANOTHER DEVICE AND NO REPORT OF DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19773537 ↗MalfunctionFeb 23, 2024Use of Device Problem; Use of Device Problem
THE USER FACILITY REPORTED VIA MEDWATCH REPORT THAT THEIR EXACTO COLD SNARE WAS NOT CUTTING TO THEIR DOCTOR'S SATISFACTION. NO REPORT OF INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18769072 ↗MalfunctionJan 29, 2024Break; Break
THE USER FACILITY REPORTED VIA VIGILANCE REPORT THAT DURING A PATIENT PROCEDURE THE HANDLE TO THEIR EXACT COLD SNARE "BROKE INTO PIECES". THE PROCEDURE WAS COMPLETED SUCCESSFULLY, AND NO INJURIES WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18603009 ↗MalfunctionAug 31, 2023Break; Break
THE USER FACILITY REPORTED VIA MEDWATCH REPORT (B)(4), THAT DURING A PATIENT PROCEDURE THEIR EXACTO COLD SNARE HANDLE BROKE INTO TWO PIECES. USER FACILITY PERSONNEL UTILIZED ANOTHER DEVICE, AND THE PATIENT PROCEDURE WAS COMPLETED SUCCESSFULLY. NO REPORT OF INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17663505 ↗MalfunctionJul 28, 2023Difficult to Open or Close; Difficult to Open or Close
THE USER FACILITY REPORTED VIA A VIGILANCE REPORT (TECHNICAL COMPLAINT) TO ANVISA THAT THE HANDLE TO THEIR EXACTO COLD SNARE WOULD NOT OPEN AFTER BEING REMOVED FROM THE PACKAGING. THERE WAS NO PATIENT INVOLVEMENT AS THIS WAS IDENTIFIED PRIOR TO USE. NO REPORT OF INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17415108 ↗MalfunctionJul 14, 2023Activation Problem; Activation Problem
THE USER FACILITY REPORTED THAT DURING A PATIENT PROCEDURE THEIR EXACTO COLD SNARE FAILED TO CUT THROUGH A CECAL POLYP IN ITS ENTIRETY. THE PROCEDURE WAS CONSIDERED NOT COMPLETED, WITH A RECOMMENDATION FOR THE PATIENT TO FOLLOW-UP IN SIX MONTHS TO A YEAR. NO REPORT OF INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17328928 ↗MalfunctionJun 16, 2023Break; Insufficient Device Problem Information; Break; Insufficient Device Problem Information
THE DISTRIBUTOR REPORTED THAT DURING A PATIENT PROCEDURE, THE EXACTO COLD SNARE LOOP BROKE IN THE COLON. THE LOOP WAS RETRIEVED, AND USER FACILITY PERSONNEL UTILIZED ANOTHER DEVICE TO COMPLETE THE PROCEDURE. NO REPORT OF INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17142746 ↗MalfunctionMay 24, 2023Break; Break
THE USER FACILITY REPORTED VIA MEDWATCH REPORT MW5117151 THAT THE HANDLE OF THEIR EXACTO COLD SNARE BROKE IN HALF DURING A COLONOSCOPY BIOPSY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A DIFFERENT EXACTO COLD SNARE. NO REPORT OF INJURY OR PROCEDURE DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16993064 ↗MalfunctionMay 12, 2023Activation Problem; Activation Problem
THE USER FACILITY REPORTED VIA MEDWATCH REPORT 3900490000-2023-8008 THAT DURING A PATIENT PROCEDURE THEIR EXACTO COLD SNARE WAS BEING UTILIZED TO CUT A POLYP. WHILE USING THE DEVICE, THE HANDLE BROKE AND THE DOCTOR PULLED THE SNARE TO CUT THE POLYP TO COMPLETE THE PROCEDURE. NO INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16918144 ↗MalfunctionApr 7, 2023Detachment of Device or Device Component; Detachment of Device or Device Component
THE USER FACILITY REPORTED VIA MEDWATCH REPORT (B)(4) THAT DURING A PATIENT PROCEDURE THEIR EXACTO COLD SNARE DID RESECT PROPERLY. WHEN THE USER WAS BRINGING THE SNARE OUT OF THE SCOPE CHANNEL A PIECE OF THE PLASTIC CATHETER WAS OBSERVED TO BE BROKEN OFF. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AND NO INJURIES WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16700229 ↗MalfunctionMar 16, 2023Difficult to Open or Close; Difficult to Open or Close
THE USER FACILITY REPORTED VIA MEDWATCH REPORT (B)(4), THAT DURING PATIENT PROCEDURES THEIR EXACTO COLD SNARES REMAINED OPENED AND WERE NOT OPERATING PROPERLY. USER FACILITY PERSONNEL UTILIZED ANOTHER DEVICE, AND THE PATIENT PROCEDURE WAS COMPLETED SUCCESSFULLY. NO REPORT OF INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16557699 ↗MalfunctionFeb 15, 2023Break
DURING A COLONOSCOPY PROCEDURE I REMOVED A SMALL POLYP WITH A COLD SNARE DEVICE. THE POLYP WAS REMOVED PER NORMAL AND SITE LOOKED GOOD, HOWEVER WHEN I REMOVED (PULLED) SNARE FROM THE SCOPE AND WITH INSPECTION I NOTICED THE SNARE WAS OPEN. THE SNARE LOST OPEN AND CLOSE FUNCTIONALITY. LIKE MAYBE A LIKE BROKE OR SNAPPED. THE DOCTOR AND RN WERE AWARE OF INCIDENT AND PROCEDURE WAS COMPLETED WITHOUT AND FURTHER ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16378119 ↗MalfunctionNov 11, 2022Unintended Movement; Unintended Movement
THE USER FACILITY REPORTED THAT DURING A PATIENT PROCEDURE THEIR EXACTO COLD SNARE INADVERTENTLY CAME OUT OF THE CATHETER SIDEWAYS RESULTING IN A SUPERFICIAL LESION ON THE PATIENT. THE EXACTO COLD SNARE WAS REMOVED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY.
Patient problems: Laceration(s)
MAUDE report 15781463 ↗
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
- 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
- NAKAO 00230AConmed Corporation · SNARE, NON-ELECTRICAL11 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.