Acusnare G22703Recalls & reported problems
Cook Incorporated · Acusnare Polypectomy Snare Soft · Class 2
All models of Acusnare (14)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 13
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00827002227033), received between Oct 15, 2018 and Dec 22, 2025 — classified as 13 malfunctions.
The most frequently reported specific device problem is “Failure to Conduct” (3 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Failure to Conduct3
- Material Twisted/Bent3
- Off-Label Use3
- Material Frayed2
- Deformation Due to Compressive Stress1
- Failure to Cut1
- Material Separation1
- Nonstandard Device1
Patient problems
- No Clinical Signs, Symptoms or Conditions11
- No Consequences Or Impact To Patient2
Recent adverse event reports
The 13 most recent of 13 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 22, 2025Nonstandard Device; Material Separation; Deformation Due to Compressive Stress; Nonstandard Device; Material Separation; Deformation Due to Compressive Stress
DURING AN UNKNOWN ENDOSCOPIC PROCEDURE, THE PHYSICIAN USED A COOK ACUSNARE POLYPECTOMY SNARE SOFT. THE DEVICE WAS RECEIVED ON 01DEC2025 AND IT WAS DETERMINED THAT THE SNARE HEAD CANNOT BE ADVANCED DUE TO A DISCONNECTION IN THE HANDLE [SUBJECT OF REPORT]. ON 04DEC2025, IT WAS REPORTED BY THE CUSTOMER THAT THE SNARE WAS USED COLD [AGAINST IFU] AND WOULD CUT BUT NOT EXTEND. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23866427 ↗MalfunctionDec 12, 2025Failure to Conduct; Failure to Conduct
DURING A DIAGNOSTIC COLONOSCOPY, THE PHYSICIAN USED FOUR COOK ACUSNARE POLYPECTOMY SNARE SOFT. IT WAS REPORTED THAT THE SNARES ARE GETTING STUCK IN THE TISSUE HALFWAY THROUGH [WHEN ELECTROSURGICAL GENERATOR IS ACTIVATED, NO ELECTROSURGICAL CURRENT PRESENT AT SNARE HEAD], CAUSING THEM TO FORCE THE SNARE CLOSED ALL THE WAY. THIS IS CAUSING THE BUCKLING AT THE HANDLE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23789712 ↗MalfunctionDec 2, 2025Failure to Cut; Failure to Cut
DURING A DIAGNOSTIC COLONOSCOPY, THE PHYSICIAN USED A COOK ACUSNARE POLYPECTOMY SNARE SOFT. IT WAS REPORTED THAT THE SNARE DID NOT QUITE CUT WHEN THEY WERE TRYING TO GET THE POLYP. AT THE TIP BY THE HAND PIECE, THE SHEATH COILED UP. THE SNARE WAS USED HOT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER DEVICE OF THE SAME TYPE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23696718 ↗MalfunctionDec 2, 2025Off-Label Use; Off-Label Use
DURING A DIAGNOSTIC COLONOSCOPY, THE PHYSICIAN USED A COOK ACUSNARE POLYPECTOMY SNARE SOFT. IT WAS REPORTED [THAT] THE [SNARE] DID NOT QUITE CUT WHEN THEY WERE TRYING TO GET THE POLYP. AT THE TIP BY THE HAND PIECE, THE SHEATH COILED UP. THE SNARE WAS USED COLD. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER DEVICE OF THE SAME TYPE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23696627 ↗MalfunctionDec 30, 2024Failure to Conduct; Failure to Conduct
DURING A POLYPECTOMY PROCEDURE IN THE COLON, THE PHYSICIAN USED A COOK ACUSNARE POLYPECTOMY SNARE SOFT. IT WAS REPORTED THAT THE POWER DID NOT WORK. IT WOULD NOT BURN HOT. IT WAS CONFIRMED THAT THE ELECTROSURGICAL GENERATOR WORKED PROPERLY WITH OTHER DEVICES. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WIT A COMPETITIVE SNARE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21036057 ↗MalfunctionApr 12, 2024Failure to Conduct; Failure to Conduct
DURING A COLONOSCOPY, THE PHYSICIAN USED A COOK ACUSNARE POLYPECTOMY SNARE SOFT. IT WAS REPORTED THAT THE DIATHERMY DID NOT WORK. THERE WAS ALSO NO POWER TRANSMITTED FOR PROPOSED POLYPECTOMY. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19099712 ↗MalfunctionApr 12, 2024Retraction Problem; Material Twisted/Bent; Retraction Problem; Material Twisted/Bent
DURING A COLONOSCOPY, THE PHYSICIAN USED A COOK ACUSNARE POLYPECTOMY SNARE SOFT. IT WAS REPORTED THAT THE USER WAS UNABLE TO FULLY EXTEND OR RETRACT THE SNARE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19098641 ↗MalfunctionJan 2, 2024Off-Label Use; Off-Label Use
DURING MULTIPLE COLONOSCOPY PROCEDURES, THE PHYSICIAN USED MULTIPLE COOK ACUSNARE POLYPECTOMY SNARE SOFT [DEVICES]. IT WAS REPORTED [THAT] THEY ARE HAVING PROBLEMS WHEN COLD SNARING (WHICH IS OFF LABEL). THIS PROBLEM HAS OCCURRED MULTIPLE TIMES WITH THREE DIFFERENT LOTS (CAPTURED IN SEPARATE REPORTS). WHEN THEY GO TO CLOSE IT, THEY HAVE VERY LITTLE FEELING AS TO HOW THE DEVICE IS WORKING. IT IS NOT CUTTING THROUGH THE POLYP [SUBJECT OF REPORT] AND THE POLYP OFTEN ENDS UP TEARING OFF WHEN THEY PULL THE CATHETER. THEY ARE NOT HAVING ANY PROBLEMS WHEN THEY USE THEM HOT [NO PROBLEMS WHEN USED ACCORDING TO IFU]. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18427335 ↗MalfunctionJan 2, 2024Off-Label Use; Off-Label Use
DURING MULTIPLE COLONOSCOPY PROCEDURES, THE PHYSICIAN USED MULTIPLE COOK ACUSNARE POLYPECTOMY SNARE SOFT [DEVICES]. IT WAS REPORTED [THAT] THEY ARE HAVING PROBLEMS WHEN COLD SNARING (WHICH IS OFF LABEL). THIS PROBLEM HAS OCCURRED MULTIPLE TIMES WITH THREE DIFFERENT LOTS (CAPTURED IN SEPARATE REPORTS). WHEN THEY GO TO CLOSE IT, THEY HAVE VERY LITTLE FEELING AS TO HOW THE DEVICE IS WORKING. IT IS NOT CUTTING THROUGH THE POLYP [SUBJECT OF REPORT] AND THE POLYP OFTEN ENDS UP TEARING OFF WHEN THEY PULL THE CATHETER. THEY ARE NOT HAVING ANY PROBLEMS WHEN THEY USE THEM HOT [NO PROBLEMS WHEN USED ACCORDING TO IFU]. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18427313 ↗MalfunctionDec 3, 2021Material Twisted/Bent; Material Twisted/Bent
DURING TWO (2) SEPARATE POLYPECTOMY PROCEDURES, THE PHYSICIAN USED A COOK ACUSNARE POLYPECTOMY SNARE SOFT (ONE DEVICE IN EACH PROCEDURE). AS THEY'RE CUTTING THROUGH THE POLYPS WITH THE SNARES, THE SNARE SHEATHS JUST DISTAL TO THE HANDLES WOULD BUCKLE TO THE POINT WHERE THEY WOULDN'T BE ABLE TO CUT THROUGH THE POLYPS (OR FINISH THE POLYPECTOMY. IN ORDER TO COMPLETE THE PROCEDURES, THEY HAD TO OPEN THE SNARES BACK UP TO MANUALLY REINFORCE IT WITH THEIR FINGERS. ALL THIS HAPPENED WHILE THE DEVICES REMAINED IN THE SCOPES DURING THE PROCEDURES. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12926924 ↗MalfunctionJun 2, 2021Material Twisted/Bent; Material Twisted/Bent
DURING A POLYPECTOMY, THE PHYSICIAN USED A COOK ACUSNARE POLYPECTOMY SNARE SOFT. THE CATHETER WAS CRIMPING [KINKING] NEAR THE HANDLE WHEN THEY GO AROUND THE POLYP, SO IT DOES NOT CUT PROPERLY. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11919064 ↗MalfunctionJan 28, 2021Material Frayed; Material Frayed
DURING A COLONIC POLYPECTOMY, THE PHYSICIAN USED A COOK ACUSNARE POLYPECTOMY SNARE SOFT. THE SNARE WAS ADVANCED TO THE END OF THE SCOPE, OLYMPUS PCF-H180, AND WHEN SNARE WAS OPENED IT WAS NOTED THE DISTAL END WAS FRAYING. THE SNARE WAS REMOVED AND ANOTHER OF THE SAME DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTABLE INFORMATION AT THIS TIME. OUR EVALUATION OF THE RETURNED DEVICE ON 12/31/2020 DETERMINED THAT THE SNARE HEAD WAS FRAYED/UNRAVELED. DURING RETRACTION THERE WAS SOME FRICTION NOTED WHEN THE FRAYED PORTION OF THE SNARE ENTERED THE CATHETER AND WAS SHARP [SUBJECT OF REPORT]. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 11245904 ↗MalfunctionOct 15, 2018Material Frayed; Material Frayed
DURING A COLONIC POLYPECTOMY, THE PHYSICIAN USED A COOK ACUSNARE POLYPECTOMY SNARE SOFT. THE SNARE WAS NOT OPENED AND TESTED PRIOR TO USAGE. THE SNARE WAS INTRODUCED DOWN BIOPSY CHANNEL OF COLONOSCOPE, THEN IT WAS OPENED TO PERFORM POLYPECTOMY. THE WIRE OF SNARE [SNARE HEAD] OBSERVED TO BE FAULTY AS IT APPEARED DAMAGED AND "FRAYED." THE DEVICE WAS REMOVED FROM THE COLONOSCOPE PRIOR TO BEING USED FOR POLYPECTOMY. THE DAMAGE IS VISIBLE ON INSPECTION, ESPECIALLY TO THE VERY TIP OR DISTAL END OF SNARE. PER THE SALES REP, "THE DEFECT IS QUITE OBVIOUS UPON LOOKING AT THE SNARE. THE ¿FRAYING¿ WAS IN THE VERY TIP OF THE SNARE (AT THE TOP), AND THE WIRES APPEARED TO BE SHARP." A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7967299 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- 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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