Acusnare G22633Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 00827002226333), received between Apr 10, 2017 and Apr 21, 2026 — classified as 1 injury, 19 malfunctions.

The most frequently reported specific device problem is “Off-Label Use” (9 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 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 21, 2026Off-Label Use

  DURING AN UNKNOWN ENDOSCOPIC PROCEDURE, THE PHYSICIAN USED A COOK ACUSNARE POLYPECTOMY SNARES. IT WAS REPORTED THAT THE SNARE DID NOT CUT PROPERLY. A LARGE SNARE WAS USED TO FINISH THE PROCEDURE. 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 24940578 ↗
• MalfunctionDec 12, 2025Failure to Conduct; Failure to Conduct

  DURING A POLYPECTOMY IN THE COLON, THE PHYSICIAN USED TWO COOK ACUSNARE POLYPECTOMY SNARES. IT WAS REPORTED THAT THE SNARES WERE UNABLE TO REMOVE THE POLYP TISSUE [WHEN ELECTROSURGICAL GENERATOR IS ACTIVATED, NO ELECTROSURGICAL CURRENT PRESENT AT SNARE HEAD]. THEY USED ANOTHER DEVICE TO FINISH THE PROCEDURE. 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 23789454 ↗
• 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 WITHOUT 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 23696284 ↗
• 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 23543036 ↗
• MalfunctionNov 20, 2024Off-Label Use; Off-Label Use

  DURING MULTIPLE UNKNOWN ENDOSCOPIC PROCEDURES, THE PHYSICIAN USED THREE (3) COOK ACUSNARE POLYPECTOMY SNARE SOFT. IT WAS REPORTED THAT WHILE TRYING TO CLOSE THE SNARE, THE PLASTIC SHEATH BUNCHED UP AT THE HANDLE PREVENTING THE SNARE FROM CLOSING. UNKNOWN HOW THE PROCEDURES WERE COMPLETED. NO UNINTENDED SECTION OF THIS DEVICE REMAINED INSIDE THE PATIENT¿S BODY. THE PATIENT WAS NOT HOSPITALIZED AND DID NOT UNDERGO PROLONGED HOSPITALIZATION DUE TO THIS OCCURRENCE. THE PATIENT DID NOT EXPERIENCE A DELAY OR REQUIRE ANY ADDITIONAL PROCEDURE DUE TO THIS OCCURRENCE. THE COMPLAINANT DID NOT REPORT ANY ADVERSE EFFECTS ON THE PATIENT DUE TO THIS OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20737271 ↗
• MalfunctionJan 9, 2024Off-Label Use; Off-Label Use

  DURING AN UNKNOWN ENDOSCOPIC PROCEDURE, THE PHYSICIAN USED A COOK ACUSNARE POLYPECTOMY SNARE SOFT. IT WAS REPORTED [THAT] WHEN TRYING TO OPEN THE SNARE TO CAPTURE THE POLYP THE SNARE CONSIDERABLE AMOUNT OF FORCE WAS REQUIRED TO OPEN THE SNARE. WHEN CLOSING THE SNARE A CONSIDERABLE AMOUNT OF FORCE WAS AGAIN REQUIRED TO CLOSE. DUE TO REQUIRING EXTRA FORCE IT CAUSED THE TENSION TO SNAP BACK SO FAST IT CAUSED THE SNARE TO JUMP. 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 18474246 ↗
• MalfunctionNov 14, 2023Difficult to Open or Close; Difficult to Open or Close

  PRIOR TO USE, THE USER WAS BENCH-TOP TESTING A COOK ACUSNARE POLYPECTOMY SNARE SOFT. IT WAS REPORTED THAT DURING CLOSING/RETRACTION, WHEN ABOUT HALF WAY CLOSED, IT FELT LIKE THERE WAS A DRAG OR DELAY [RESISTANCE] IN THE TENSION ON THE WIRE. THIS OCCURRED PRIOR TO USE; THERE WAS NO IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18133574 ↗
• MalfunctionNov 14, 2023Off-Label Use; Off-Label Use

  DURING A COLONOSCOPY, THE PHYSICIAN USED A COOK ACUSNARE POLYPECTOMY SNARE SOFT. IT WAS REPORTED [THAT] THE NURSE STATED THAT, WHEN SHE WAS CLOSING THE SNARE TO SNIP OFF THE POLYP, WHEN SHE WAS ABOUT HALF WAY CLOSED, SHE FELT LIKE THERE WAS A DRAG OR DELAY RESISTANCE IN THE TENSION ON THE WIRE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH THE DEVICE IN QUESTION. 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 18133378 ↗
• MalfunctionJul 13, 2023Material Separation; Material Separation

  DURING A COLONIC POLYP REMOVAL, THE PHYSICIAN USED A COOK ACUSNARE POLYPECTOMY SNARE SOFT. IT WAS REPORTED [THAT THE] USER TOOK SNARE TO CONDUCT COLONIC POLYPS REMOVAL PROCEDURE, AFTER SUCCESSFULLY REMOVED FIRST POLYP AND READY TO REMOVE SECOND ONE WHILE FINDING OUT THE WIRE AT HANDLE BROKEN. USER THEN CHANGED TO ANOTHER SAME DEVICE TO COMPLETE THE PROCEDURE WHICH CAUSE 10 MINUTES DELAY IN PROCEDURE. 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 17316596 ↗
• MalfunctionJan 13, 2022Failure to Conduct; Failure to Conduct

  DURING A COLONOSCOPY, A COOK ACUSNARE POLYPECTOMY SNARE WAS USED. AN OLYMPUS ESG GENERATOR AND OLYMPUS ACTIVE CORD WAS USED FOR CAUTERY TO TAKE OUT A POLYP. THE USER STARTED WITH THE OLYMPUS GENERATOR AND HAD TO SWITCH TO AN ERBE GENERATOR WITH A COOK ACTIVE CORD DUE TO NOT BEING ABLE TO CAUTERIZE. WITH THE ERBE GENERATOR, CAUTERY WAS STILL NOT POSSIBLE, AND THEY TRIED ANOTHER SNARE AS A RESULT. THE SNARE DID NOT WORK WITH EITHER ESG SYSTEM. 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 13250703 ↗
• MalfunctionJan 13, 2022Failure to Conduct; Failure to Conduct

  DURING A COLONOSCOPY, A COOK ACUSNARE POLYPECTOMY SNARE WAS USED. AN OLYMPUS ESG GENERATOR AND OLYMPUS ACTIVE CORD WAS USED FOR CAUTERY TO TAKE OUT A POLYP. THE USER STARTED WITH THE OLYMPUS GENERATOR AND HAD TO SWITCH TO AN ERBE GENERATOR WITH A COOK ACTIVE CORD DUE TO NOT BEING ABLE TO CAUTERIZE. WITH THE ERBE GENERATOR, CAUTERY WAS STILL NOT POSSIBLE, AND THEY TRIED ANOTHER SNARE AS A RESULT. THE SNARE DID NOT WORK WITH EITHER ESG SYSTEM. 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 13250601 ↗
• MalfunctionJan 4, 2022Failure to Cut; Failure to Cut

  DURING A POLYPECTOMY, THE PHYSICIAN USED A COOK ACUSNARE POLYPECTOMY SNARE SOFT. THE "CUT FOR COLD/HOT SNARE DID NOT WORK (SHEATH EXPOSED)." THE USER ATTEMPTED TO COLD SNARE. THIS IS INTERPRETED TO MEAN THAT THE DEVICE WOULD NOT CUT AND THE OUTER CATHETER (SHEATH) WAS KINKED. 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 13159768 ↗
• InjuryNov 5, 2020Failure to Conduct; Failure to Conduct

  DURING MULTIPLE COLONOSCOPIES, THE PHYSICIAN USED AT LEAST TWO (2) ACUSNARE POLYPECTOMY SNARE SOFTS. THIS WAS MULTIPLE EVENTS, AT LEAST ONE OF THEM POSSIBLY OCCURRED ON (B)(6) 2020. DURING THESE EVENTS, THE CAUTERY WAS NOT WORKING PROPERLY AS IT WAS NOT CREATING HEAT OR CURRENT. THE DEVICES STILL CUT THROUGH WITHOUT HEAT, BUT THERE WAS MORE BLEEDING AND MORE CLIPS WERE REQUIRED [SUBJECT OF REPORT]. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT REQUIRED HEMOCLIPS DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT EXPERIENCED MORE BLEEDING WHICH WAS MANAGED WITH HEMOCLIPS, BUT DID NOT EXPERIENCE ANY OTHER ADVERSE EFFECTS.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 10795995 ↗
• MalfunctionJun 30, 2020Off-Label Use; Off-Label Use

  DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD), THE PHYSICIAN USED AN ACUSNARE POLYPECTOMY SNARE SOFT (SASM-1-S) ON A PATIENT OF UNKNOWN AGE AND GENDER ON (B)(6) 2020. THE DEVICE WAS COILING BY THE HANDLE SO [THE USER] WAS UNABLE TO GET A TIGHT SQUEEZE WHEN [THE USER] RETRIEVED WRITING PEN OBJECTS FOR EGD. TWO SNARES [ ACUSNARE POLYPECTOMY SNARE SOFT (SASM-1-S) AND ACUSNARE POLYPECTOMY SNARE (ASMH-1)] WERE ATTEMPTED WITH THE SAME OUTCOME AND TO FINISH THE PROCEDURE THE PHYSICIAN USED A ROTHNET SNARE WITH NO FURTHER COMPLICATIONS. THE FOLLOWING WAS RECEIVED ON 24-JUN-2020: BECAUSE THEY WERE USING THEM OFF-LABEL BY RETRIEVING FOREIGN BODIES, AS THEY WOULD TIGHTEN DOWN ON OBJECT TO GRASP AND RETRIEVE IT, THE SNARE WOULD TIGHTEN DOWN ON THE OBJECT BUT THEY COULD NOT GET GOOD PURCHASE [GRIP] SO THEY WOULD TIGHTEN MORE AND AS THEY CONTINUED TO CLOSE DOWN THE SNARE WIRE ON THE OBJECT SO AS NOT TO LOSE IT, THEY COULD DRAW BACK ON THE HANDLE BUT THE SNARE WOULDN¿T TIGHTEN BECAUSE THE SHEATH MATERIAL WAS BUCKLING JUST DISTAL TO 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 T

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10215689 ↗
• MalfunctionJun 30, 2020Off-Label Use; Off-Label Use

  DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD), THE PHYSICIAN USED AN ACUSNARE POLYPECTOMY SNARE SOFT (SASM-1-S) ON A PATIENT OF UNKNOWN AGE AND GENDER ON (B)(6) 2020. THE DEVICE WAS COILING BY THE HANDLE SO THE USER WAS UNABLE TO GET A TIGHT SQUEEZE WHEN THE USER RETRIEVED OBJECTS (AA BATTERIES) FOR THE EGD. TWO SNARES ACUSNARE POLYPECTOMY SNARE SOFT (SASM-1-S) AND ACUSNARE POLYPECTOMY SNARE (ASMH-1) WERE ATTEMPTED WITH THE SAME OUTCOME AND TO FINISH THE PROCEDURE THE PHYSICIAN USED A ROTHNET SNARE WITH NO FURTHER COMPLICATIONS. THE FOLLOWING WAS RECEIVED ON 24-JUN-2020: BECAUSE THEY WERE USING THEM OFF-LABEL BY RETRIEVING FOREIGN BODIES, AS THEY WOULD TIGHTEN DOWN ON OBJECT TO GRASP AND RETRIEVE IT, THE SNARE WOULD TIGHTEN DOWN ON THE OBJECT BUT THEY COULD NOT GET GOOD PURCHASE GRIP SO THEY WOULD TIGHTEN MORE AND AS THEY CONTINUED TO CLOSE DOWN THE SNARE WIRE ON THE OBJECT SO AS NOT TO LOSE IT, THEY COULD DRAW BACK ON THE HANDLE BUT THE SNARE WOULDN T TIGHTEN BECAUSE THE SHEATH MATERIAL WAS BUCKLING JUST DISTAL TO 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

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10215688 ↗
• MalfunctionJan 21, 2019Sharp Edges; Sharp Edges

  DURING A POLYPECTOMY PROCEDURE, THE PHYSICIAN USED A COOK ACUSNARE POLYPECTOMY SNARE SOFT. THE DEVICE WAS TAKEN OUT AND NOTED THE SNARE WAS SHARP, SO IT WAS DISCARDED AND ANOTHER OF THE SAME DEVICE WAS USED TO CONTINUE THE PROCEDURE. THERE WAS NO HARM TO THE PATIENT NOTED. OUR ATTEMPTS TO COLLECT SPECIFIC PATIENT OUTCOME INFORMATION WERE UNSUCCESSFUL. BECAUSE THE COMPLAINANT STATED THAT THERE WAS NO HARM TO THE PATIENT NOTED, WE CAN CONCLUDE THAT THIS INFORMATION DOES NOT REASONABLY SUGGEST THE PATIENT WAS ADVERSELY IMPACTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8265118 ↗
• MalfunctionJan 9, 2018Retraction Problem; Retraction Problem

  DURING A COLONOSCOPY, THE PHYSICIAN USED A COOK ACUSNARE POLYPECTOMY SNARE SOFT. THE SNARE WAS KINKED. THE FACILITY OPENED UP A NEW SNARE TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTABLE INFORMATION AT THIS TIME. THE FOLLOWING ADDITIONAL INFORMATION WAS RECEIVED ON 12/15/2017: THE SNARE KINKING RESULTED IN DIFFICULTY RETRACTING THE SNARE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7175712 ↗
• MalfunctionOct 31, 2017Retraction Problem; Retraction Problem

  DURING AN ENDOSCOPIC PROCEDURE THE PHYSICIAN USED A COOK ACUSNARE POLYPECTOMY SNARE SOFT. THE SNARE WAS STICKING ON OPENING AND CLOSING.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6990655 ↗
• MalfunctionOct 4, 2017Off-Label Use; Failure to Cut; Off-Label Use; Failure to Cut

  DURING A COLONOSCOPY, THE PHYSICIAN USED TWO (2) COOK ACUSNARE POLYPECTOMY SNARES SOFT. AS REPORTED TO CUSTOMER RELATIONS: "WHEN THE FACILITY TRIED TO CLOSE THE SNARE, IT WOULD NOT CUT THROUGH THE POLYP AND THE PLASTIC CATHETER STARTED CRIMPING AT THE HANDLE END. A SECOND DEVICE WAS OPENED AND THE VERY SAME EVENT OCCURRED. A THIRD ACUSNARE POLYPECTOMY SNARES SOFT WAS OPENED FROM A DIFFERENT LOT NUMBER AND THIS DEVICE WAS USED SUCCESSFULLY TO COMPLETE THE PROCEDURE." ADDITIONAL INFORMATION RECEIVED ON 09/12/2017: THE TWO (2) COMPLAINT DEVICES THAT MADE SCOPE CONTACT AND PATIENT CONTACT WERE DISCARDED BY THE FACILITY AND WILL NOT BE RETURNED. ONE (1) DEVICE WAS OPENED TO TEST (NO SCOPE OR PATIENT CONTACT) ON A PIECE OF CELERY [PRIOR TO USE]. THIS DEVICE IS BEING RETURNED. FURTHERMORE, THE CUSTOMER PULLED THEIR REMAINING STOCK FROM LOT NUMBER W3903583. ADDITIONAL INFORMATION WAS PROVIDED FROM THE DISTRICT MANAGER THAT THE USER WAS COLD SNARING.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6913438 ↗
• MalfunctionApr 10, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE PHYSICIAN USED A COOK ACUSNARE POLYPECTOMY SNARE SOFT. THE SNARE FRAYED AFTER THEY REMOVED THE POLYP LEAVING A BLACK CHAR ON THE TISSUE. BASED ON THE ADDITIONAL QUESTIONS ANSWERED BY THE AREA REPRESENTATIVE THE DEVICE ALLOWED CUTTING, BUT DID NOT COAGULATE/BURN PROPERLY. THE FOLLOWING CLARIFICATION WAS RECEIVED ON 3/22/17: IT [THE FRAYED SNARE] DID NOT FORM A SHARP POINT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6478113 ↗