Acusnare G22704Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00827002227040), received between Oct 18, 2016 and Dec 2, 2025 — classified as 3 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Off-Label Use” (4 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.

Most reported problems

Recent adverse event reports

The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 2, 2025Off-Label Use; Off-Label Use

  DURING AN UNSPECIFIED POLYPECTOMY THE PHYSICIAN USED A COOK ACUSNARE POLYPECTOMY SNARE. IT WAS REPORTED THAT THE PRODUCT WOULD OPEN AND CLOSE FINE. WHEN TRYING TO GRAB THE POLYP THE PRODUCT WOULD BUNCH UP INSTEAD OF CUTTING THROUGH [SNARE WILL NOT CUT THROUGH ENTIRE POLYP - SUBJECT OF REPORT]. THE SNARE WAS USED WITH NO CAUTERY. 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 23696253 ↗
• MalfunctionNov 13, 2025Off-Label Use; Off-Label Use

  DURING AN UNSPECIFIED POLYPECTOMY THE PHYSICIAN USED A COOK ACUSNARE POLYPECTOMY SNARE. IT WAS REPORTED THAT THE PRODUCT WOULD OPEN AND CLOSE FINE. WHEN TRYING TO GRAB THE POLYP THE PRODUCT WOULD BUNCH UP INSTEAD OF CUTTING THROUGH [SNARE WILL NOT CUT THROUGH ENTIRE POLYP - 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 23543008 ↗
• MalfunctionAug 15, 2025Difficult to Open or Close

  SNARE WOULD NOT OPEN PROPERLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22814581 ↗
• MalfunctionMay 23, 2025Device Handling Problem; Device Handling Problem

  IN PREPARATION FOR A PROCEDURE, THE USER SELECTED A COOK ACUSNARE POLYPECTOMY SNARE SOFT. IT WAS REPORTED [THAT] THE SNARE WAS TESTED FOR FUNCTIONALITY. WHEN TESTING THE RETRACTION OF THE SNARE INTO THE TUBE OF THE DEVICE BODY, IT WAS OBSERVED THAT, WHEN APPLYING THE NECESSARY RETRACTION PRESSURE, THE MATERIAL OF THE EXTERNAL TUBE SHOWED SIGNIFICANT DEFORMATION, COMPROMISING THE FUNCTIONALITY OF THE DEVICE AND THE SAFETY OF ITS USE. THE DEVICE WAS IMMEDIATELY ISOLATED AND REPLACED WITH ANOTHER FUNCTIONAL MATERIAL, ENSURING THE SAFE CONTINUATION OF THE PROCEDURE. CUSTOMER PROVIDED A VIDEO SHOWING KINKED DEVICE SHEATH, AS SNARE LOOP IS UNABLE TO CUT. THIS OCCURRED PRIOR TO PATIENT CONTACT; THERE WAS NO IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22077384 ↗
• MalfunctionMar 13, 2025Material Twisted/Bent; Material Twisted/Bent

  DURING AN UNKNOWN ENDOSCOPIC PROCEDURE, THE PHYSICIAN USED A COOK ACUSNARE POLYPECTOMY SNARE SOFT. IT WAS REPORTED [THAT] WHEN CAPTURING THE POLYP AND PROCEEDING WITH THE CUT, THE PLASTIC PART WRINKLED AND NO CURRENT PASSED. 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 21593295 ↗
• MalfunctionJun 1, 2023Failure to Cut; Failure to Cut

  DURING AN UNKNOWN ENDOSCOPIC PROCEDURE, THE PHYSICIAN USED THREE COOK ACUSNARE POLYPECTOMY SNARE SOFT. IT WAS REPORTED [THAT] THE PHYSICIAN FELT THAT THE SNARE HUNG/TUGGED ON THE TISSUE WHILE TRYING TO CUT THROUGH THE TISSUE. 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 17038249 ↗
• InjuryFeb 13, 2023Off-Label Use; Off-Label Use

  DURING A POLYPECTOMY PROCEDURE, THE PHYSICIAN USED A COOK ACUSNARE POLYPECTOMY SNARE SOFT. IT WAS REPORTED THAT THEY USED A COLD [SNARE] LOOP TO REMOVE A POLYP, [SNARE] DID NOT CUT, AND SHEATH PLEATED ABNORMAL USE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT'S BODY. THE PATIENT EXPERIENCED TORN MUCOSA, AND REQUIRED A CLIP ON THE TEAR AND ELECTROCAUTERY. NO FURTHER INFORMATION WAS PROVIDED BY THE INITIAL REPORTER.

  Patient problems: Gastrointestinal Hemorrhage

  MAUDE report 16363117 ↗
• MalfunctionJun 17, 2021Failure to Cut; Failure to Cut

  DURING A POLYPECTOMY, THE PHYSICIAN USED A COOK ACUSNARE POLYPECTOMY SNARE SOFT. THE SNARE WOULD NOT CUT THROUGH THE POLYPS. 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 12016291 ↗
• MalfunctionApr 30, 2021Off-Label Use; Off-Label Use

  DURING A POLYPECTOMY PROCEDURE, THE PHYSICIAN USED A COOK ACUSNARE POLYPECTOMY SNARE SOFT. DURING USE TO CUT A POLYP, THE SHEATH TWIRLED ON ITSELF AND THE POLYP WAS NOT CUT AT ALL. THE PHYSICIAN ATTEMPTED TO COLD SNARE THE POLYP. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. 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 11752433 ↗
• InjuryAug 31, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  DURING A POLYPECTOMY PROCEDURE, THE PHYSICIAN USED A COOK ACUSNARE POLYPECTOMY SNARE SOFT. THE HEAD OF THE SNARE DETACHED IN THE PATIENT. THE PHYSICIAN GOT IT REMOVED SUCCESSFULLY, AND THERE WERE NO ADVERSE EFFECTS TO THE PATIENT. THEY COMPLETED PROCEDURE WITH ANOTHER SNARE. THE FOLLOWING WAS RECEIVED ON (B)(6) 2018: THE PORTION OF THE SNARE DETACHED WHEN THE DEVICE WAS BEING CLOSED. THE DETACHED PORTION OF THE SNARE WAS REMOVED WITH FORCEPS. IT IS UNKNOWN HOW MANY POLYPS WERE REMOVED PRIOR TO DETACHMENT, AND THERE ARE NO ENDOSCOPIC PHOTOS AVAILABLE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE DETACHED PORTION OF THE SNARE WAS RETRIEVED WITH FORCEPS. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: Foreign Body In Patient

  MAUDE report 7838291 ↗
• InjuryFeb 7, 2018Failure to Conduct; Failure to Conduct

  DURING A COLONOSCOPY, THE PHYSICIAN USED A COOK ACUSNARE POLYPECTOMY SNARE SOFT. THE SNARE DID NOT IGNITE FOR CAUTERY. THE SNARE WAS COLD. THE FOLLOWING ADDITIONAL INFORMATION WAS RECEIVED (B)(6) 2018 FROM THE COOK AREA REPRESENTATIVE: MY UNDERSTANDING IS THAT IT WAS SUPPOSED TO BE HOT SNARE AND IT DID NOT GET HOT. SECOND, I THINK THEY USED A COUPLE CLIPS AFTER THE POLYP WAS REMOVED COLD AND NOT BIOPSY FORCEPS. BUT, YOU CAN CONFIRM WITH THE FACILITY IF DIFFERENT. THIS IS JUST MY UNDERSTANDING OR WHAT I THINK WHAT HAPPENED. THE FOLLOWING WAS RECEIVED FROM THE REPORTER AT THE USER FACILITY ON 01/25/18: THE PHYSICIAN USED FORCEPS TO STOP THE BLEEDING. I AM NOT FAMILIAR WITH THE PROCEDURE. HOWEVER, BY THE WAY THE PHYSICIAN DESCRIBED THE EVENT, YES, THE PHYSICIAN ATTEMPTED THE PROCEDURE WITH THE SNARE AS A HOT BIOPSY. THE FOLLOWING ADDITIONAL INFORMATION WAS PROVIDED FROM THE AREA REPRESENTATIVE ON (B)(6) 2018: I THINK WHAT THEY MEAN IS THE SNARE WAS USED COLD TO REMOVE TISSUE BECAUSE CAUTERY DID NOT WORK. CLARIFICATION WAS RECEIVED FROM THE AREA REPRESENTATIVE ON (B)(6) 2018 INDICATING THAT THE FACILITY WOULD NOT HAVE PRE-TESTED THE DEVICE OUTSIDE THE PATIENT AND WOULD HAVE NOTICED [NO

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Hemostasis

  MAUDE report 7249497 ↗
• MalfunctionOct 18, 2016Failure to Conduct; Failure to Conduct

  DURING A POLYPECTOMY, THE PHYSICIAN USED A COOK ACUSNARE POLYPECTOMY SNARE SOFT. AS REPORTED TO CUSTOMER RELATIONS: "WHEN THE DEVICE WAS HOOKED UP TO CAUTERY IT WOULD NOT WORK." THE FOLLOWING ADDITIONAL INFORMATION PROVIDED WAS PROVIDED ON, (B)(6) 2016: "NO ADDITIONAL PROCEDURES OR INTERVENTION WAS REQUIRED. THE TECHNICIAN USED A NEW SNARE, A NEW ACTIVE CORD AND A NEW ELECTROSURGICAL GENERATOR TO COMPLETE THE PROCEDURE." THE FOLLOWING INFORMATION WAS PROVIDED FROM MEDWATCH REPORT ((B)(4)), RECEIVED (B)(6) 2016: "MD [PHYSICIAN] WANTED TO USE "HOT SNARE" (POLYPECTOMY WITH CAUTERY) SNARE PLACED AROUND POLYP, BUT CAUTERY WOULD NOT WORK WITH THE SNARE CAUTERY MACHINE. [THE SNARE CAUTERY MACHINE WAS] USED PREVIOUSLY WITHOUT PROBLEM SO SNARE WAS SWITCHED. NO HARM TO PT [PATIENT]."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6037931 ↗