ExactoRecalls & reported problems across all models
US Endoscopy · 3 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 41
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls
- 0
We found 3 models of Exacto by US Endoscopy in the FDA's device registry (GUDID). Together they are named in 41 adverse event reports in the FDA's MAUDE database, received between Dec 28, 2020 and Sep 9, 2026 — classified as 1 injury, 40 malfunctions.
The most frequently reported specific device problem is “Break” (12 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported Exacto problems
Device problems
- Break12
- Insufficient Device Problem Information9
- Detachment of Device or Device Component6
- Difficult to Open or Close5
- 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 Conditions34
- Insufficient Information2
- Laceration(s)2
- Foreign Body In Patient1
- Hematoma1
- Perforation1
Exacto models
3 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Exacto 00711115SNARE, NON-ELECTRICAL35 reports
- Exacto 00711094SNARE, NON-ELECTRICAL3 reports
- Exacto 00711095SNARE, NON-ELECTRICAL3 reports
Recent Exacto adverse event reports
The 15 most recent reports across all models, 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 ↗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 ↗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 ↗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 ↗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 ↗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 ↗
Other US Endoscopy products
All US Endoscopy devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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