Acusnare G22647Recalls & reported problems

Summary

The FDA's MAUDE database contains 37 adverse event reports that list this exact device (DI 00827002226470), received between May 20, 2016 and Apr 29, 2026 — classified as 37 malfunctions.

The most frequently reported specific device problem is “Retraction Problem” (21 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.

Most reported problems

Recent adverse event reports

The 25 most recent of 37 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 29, 2026Material Deformation

  IN PREPARATION FOR A PROCEDURE, THE USER SELECTED A COOK COOK ACUSNARE POLYPECTOMY SNARE. IT WAS REPORTED [THAT] THE SNARE APPEARED BENT AND NOT IN THE EXPECTED SHAPE. 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 25032393 ↗
• MalfunctionApr 11, 2026Material Deformation

  IN PREPARATION FOR A PROCEDURE, THE USER SELECTED A COOK COOK ACUSNARE POLYPECTOMY SNARE. IT WAS REPORTED [THAT] THE SNARE APPEARED BENT AND NOT IN THE EXPECTED SHAPE. 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 24846423 ↗
• MalfunctionMay 26, 2023Material Separation; Material Separation

  DURING A COLONOSCOPY WITH POLYP REMOVAL, THE PHYSICIAN USED A COOK ACUSNARE POLYPECTOMY SNARE. IT WAS REPORTED, [THAT THE] SNARE FUNCTIONED FINE PRIOR TO BEING PLACED DOWN ENDOSCOPE. AND DURING PROCEDURE, POLYPECTOMY WAS PERFORMED WITHOUT INCIDENT. AND PROBLEM NOTED, WHEN REMOVING SNARE FROM SCOPE. SHEATH COVERING WIRES SEPARATED AT HANDLE AND WAS PULLED OFF. NO OTHER DEVICE WAS REQUIRED TO COMPLETE THE PROCEDURE. THE DEVICE WAS EVALUATED ON (B)(6) 2023. THE RED HUB ON THE HANDLE IS BROKEN. AND THE SNARE WIRE IS REMOVED FROM THE SHEATH TUBING. 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 17010292 ↗
• MalfunctionApr 7, 2021Retraction Problem; Retraction Problem

  DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD), THE PHYSICIAN USED A COOK ACUSNARE POLYPECTOMY SNARE. THE PHYSICIAN WAS ABLE TO OPEN IT TO GET THE SNARE WIRE OUT OF THE SHEATH. BUT, HE HAD A LOT OF DIFFICULTY AND RESISTANCE WHEN CLOSING IT [SUBJECT OF REPORT]. HE SUCCESSFULLY COMPLETED THE PROCEDURE WITH ANOTHER SNARE FROM THE SAME LOT. 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 11626620 ↗
• MalfunctionJan 7, 2021Difficult to Open or Close; Difficult to Open or Close

  DURING AN ENDOSCOPIC POLYPECTOMY PROCEDURE, THE PHYSICIAN USED A COOK ACUSNARE POLYPECTOMY SNARE. THE DUCK BILL SNARE WAS NOT OPENING AND CLOSING PROPERLY DURING THE PROCEDURE. THE CUSTOMER STATED THAT SHE FEELS LIKE SHE HAS TISSUE WHEN SHE CLOSES, BUT DOES NOT ACTUALLY HAVE TISSUE. IT IS NOT A SMOOTH CLOSE. SHE SAID THAT SHE FEELS LIKE THE DEVICE STILL NEEDS TO BE CLOSED AFTER IT IS CLOSED. 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 11131422 ↗
• MalfunctionDec 16, 2020Failure to Conduct; Failure to Conduct

  DURING A POLYPECTOMY, THE PHYSICIAN USED TWO (2) COOK ACUSNARE POLYPECTOMY SNARES. THE SNARES WOULD NOT OPEN AND CLOSE CORRECTLY. ONCE THEY GOT THEM OPEN, THEY WOULD NOT CUT THROUGH THE POLYP. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A COMPETITIVE SNARE. ADDITIONAL INFORMATION PROVIDED INDICATES THAT THE DEVICE DID NOT ALLOW ANY TRANSFER OF ELECTRICAL POWER. 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 11020137 ↗
• MalfunctionDec 11, 2020Failure to Cut; Failure to Cut

  DURING AN POLYPECTOMY IN THE COLON, THE PHYSICIAN USED A COOK ACUSNARE POLYPECTOMY SNARE AND STATED THAT IT WOULD NOT CAUTERIZE. THEY WERE ABLE TO SUCCESSFULLY COMPLETE THE PROCEDURE WITH A DIFFERENT 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 Consequences Or Impact To Patient

  MAUDE report 10993003 ↗
• MalfunctionDec 11, 2020Failure to Cut; Failure to Cut

  DURING AN POLYPECTOMY IN THE COLON, THE PHYSICIAN USED A COOK ACUSNARE POLYPECTOMY SNARE AND STATED THAT IT WOULD NOT CAUTERIZE. THEY WERE ABLE TO SUCCESSFULLY COMPLETE THE PROCEDURE WITH A DIFFERENT SNARE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENTS 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 10992985 ↗
• MalfunctionDec 10, 2020Retraction Problem; Retraction Problem

  DURING AN ENDOSCOPIC POLYPECTOMY, THE PHYSICIAN USED A COOK ACUSNARE POLYPECTOMY SNARE. THE HOUSING OVER THE SNARE WIRE, NEAR THE HANDLE, WAS BUCKLING OR WRINKLING. IT WAS NOT CLOSING EFFECTIVELY. THEN IT WOULD SNAP SHUT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A DIFFERENT CRESCENT 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 Consequences Or Impact To Patient

  MAUDE report 10985840 ↗
• MalfunctionDec 8, 2020Difficult to Open or Close; Difficult to Open or Close

  THE FOLLOWING WAS INITIALLY REPORTED: "DURING MULTIPLE ENDOSCOPIC POLYPECTOMY PROCEDURES, THE PHYSICIAN USED MULTIPLE COOK ACUSNARE POLYPECTOMY SNARES. THE DUCK BILL SNARES WERE NOT OPENING AND CLOSING PROPERLY [SUBJECT OF REPORT] DURING THE PROCEDURE. MULTIPLE ATTEMPTS FOR THE EXACT QUANTITY WERE COMPLETED, BUT THE QUANTITY REMAINS UNKNOW." PER ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2020 THE CUSTOMER STATED THAT SHE FEELS LIKE SHE HAS TISSUE WHEN SHE CLOSES BUT DOES NOT ACTUALLY HAVE TISSUE. IT IS NOT A SMOOTH CLOSE. SHE SAID THAT SHE FEELS LIKE THE DEVICE STILL NEEDS TO BE CLOSED AFTER IT IS CLOSED. THE CUSTOMER CONFIRMED THAT THERE WERE FIVE (5) USED COMPLAINT DEVICES. 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 10967746 ↗
• MalfunctionDec 2, 2020Retraction Problem; Failure to Advance; Retraction Problem; Failure to Advance

  DURING AN ENDOSCOPIC POLYPECTOMY, THE PHYSICIAN USED A COOK ACUSNARE POLYPECTOMY SNARE AND THERE WAS RESISTANCE IN OPENING AND CLOSING THE DEVICE [DIFFICULTY WITH RETRACTION SUBJECT OF REPORT]. A NEW DEVICE WAS OPENED AND USED TO COMPLETE THE INTENDED PROCEDURE SUCCESSFULLY." 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 10935060 ↗
• MalfunctionDec 2, 2020Retraction Problem; Failure to Advance; Retraction Problem; Failure to Advance

  DURING AN ENDOSCOPIC POLYPECTOMY, THE PHYSICIAN USED A COOK ACUSNARE POLYPECTOMY SNARE AND THERE WAS RESISTANCE IN OPENING AND CLOSING THE DEVICE [DIFFICULTY WITH RETRACTION SUBJECT OF REPORT]. A NEW DEVICE WAS OPENED AND USED TO COMPLETE THE INTENDED PROCEDURE SUCCESSFULLY." 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 10935059 ↗
• MalfunctionDec 2, 2020Retraction Problem; Failure to Advance; Retraction Problem; Failure to Advance

  DURING AN ENDOSCOPIC POLYPECTOMY, THE PHYSICIAN USED A COOK ACUSNARE POLYPECTOMY SNARE AND THERE WAS RESISTANCE IN OPENING AND CLOSING THE DEVICE [DIFFICULTY WITH RETRACTION SUBJECT OF REPORT]. A NEW DEVICE WAS OPENED AND USED TO COMPLETE THE INTENDED PROCEDURE SUCCESSFULLY." 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 10935020 ↗
• MalfunctionNov 30, 2020Failure to Cut; Failure to Cut

  DURING AN ENDOSCOPIC POLYPECTOMY, THE PHYSICIAN USED A COOK ACUSNARE POLYPECTOMY SNARE. WHEN THEY USED THE DEVICE WITH CAUTERY, IT WOULD NOT CUT THE TISSUE UNTIL THEY CHANGED THE SETTINGS TO MORE OF A "COAGULATION." THE SNARE DID NOT CUT ON THE "BLEND" SETTING BUT CUT ON THE "COAG." UNKNOWN IF THE GROUNDING PAD MAY HAVE BEEN IN THE WRONG POSITION. DEVICE DID WORK WELL ENOUGH TO COMPLETE 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 Consequences Or Impact To Patient

  MAUDE report 10920918 ↗
• MalfunctionNov 29, 2020Failure to Advance; Failure to Advance

  DURING AN ENDOSCOPIC POLYPECTOMY, THE PHYSICIAN USED A COOK ACUSNARE POLYPECTOMY SNARE. THE SNARE WAS DIFFICULT TO OPEN AND TO CLOSE AROUND THE POLYP. IT FINALLY DID OPEN, BUT THE PHYSICIAN DECIDED TO WITHDRAW THAT ONE (COULDN'T REMOVE THE POLYP). CUSTOMER USED ANOTHER OF THE SAME DEVICE TO COMPLETE 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 Consequences Or Impact To Patient

  MAUDE report 10916296 ↗
• MalfunctionOct 29, 2020Off-Label Use; Off-Label Use

  DURING A COLONOSCOPY, THE PHYSICIAN USED AN ACUSNARE POLYPECTOMY SNARE. THE COOK ACUSNARE POLYPECTOMY SNARE WAS DEFORMED IN THE AREA ADJACENT TO THE OPENING/CLOSING HANDLE WHEN BEING CLOSED OVER TISSUE IN THE COLON. ALSO WHEN PROPERLY GROUNDED AND HOOKED TO THE ERBE ELECTROCAUTERY MACHINE IN THE ROOM, THE SNARE DID NOT EFFICIENTLY CUT THE TISSUE AS EXPECTED (SUBJECT OF REPORT). THERE WAS NO DOCUMENTATION OF THE EVENT IN THE OPERATIVE NOTE. 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 10757228 ↗
• MalfunctionOct 23, 2020Retraction Problem; Retraction Problem

  DURING AN ENDOSCOPIC PROCEDURE, THE PHYSICIAN USED TWO (2) ACUSNARE POLYPECTOMY SNARES. THE SNARE WOULD NOT OPEN AND CLOSE. CLARIFICATION WAS RECEIVED ON 15-SEPTEMBER-2020 WHICH STATES THAT THE SNARE WOULD ADVANCE, BUT WAS VERY DIFFICULT TO ADVANCE. THE CATHETER SEEM KINKED. THE SNARE WAS VERY DIFFICULT TO RETRACT. OUR ATTEMPTS TO COLLECT ADDITIONAL INFORMATION REGARDING PATIENT OUTCOME WERE UNSUCCESSFUL. WHILE THE COMPLAINANT DID NOT SPECIFY IF THE PATIENT EXPERIENCED ANY ADVERSE EFFECTS OR REQUIRED ADDITIONAL MEDICAL PROCEDURES DUE TO THIS EVENT, THE INFORMATION ABLE TO BE COLLECTED DOES NOT REASONABLY SUGGEST THE PATIENT WAS ADVERSELY IMPACTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10725955 ↗
• MalfunctionSep 30, 2020Failure to Cut; Material Deformation

  COOK ACUSNARE POLYPECTOMY SNARE (REFERENCE (B)(4) WAS DEFORMING IN THE AREA ADJACENT TO THE OPENING/CLOSING HANDLE WHEN BEING CLOSED OVER TISSUE IN THE COLON. ALSO WHEN PROPERLY GROUNDED AND HOOKED TO THE ERBE ELECTROCAUTERY MACHINE IN THE ROOM, THE SNARE DID NOT EFFICIENTLY CUT THE TISSUE AS EXPECTED. NO DOCUMENTATION OF EVENT IN OPERATIVE NOTE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10605657 ↗
• MalfunctionSep 3, 2020Retraction Problem; Retraction Problem

  DURING A COLONOSCOPY, THE PHYSICIAN USED AN ACUSNARE POLYPECTOMY SNARE. WHEN ATTEMPTING TO REMOVE THE POLYP USING THE SNARE, IT WAS DIFFICULT TO OPEN AND ALMOST IMPOSSIBLE TO CLOSE. IT WAS REALIZED THAT THERE WAS A KINK IN THE WIRE IN THE HANDLE OF 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 Consequences Or Impact To Patient

  MAUDE report 10487601 ↗
• MalfunctionJan 15, 2019Retraction Problem; Retraction Problem

  DURING AN ENDOSCOPIC MUCOSAL RESECTION (EMR), THE PHYSICIAN USED A COOK ACUSNARE POLYPECTOMY SNARE. THE TIP [SNARE HEAD] WAS NOT PULLING INTO THE SHEATH [UNABLE TO RETRACT]. THEY WERE UNABLE TO CUT THE POLYP. PER THE USER, THE DEVICE "TWISTS LIKE THE OTHER DEVICES THAT WERE REPORTED." SEE MDRS 1037905-2018-00552, 1037905-2018-00553 AND 1037905-2018-00554 FOR PREVIOUSLY REPORTED DEVICES. 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 8250139 ↗
• MalfunctionJan 9, 2019Retraction Problem; Retraction Problem

  DURING A POLYPECTOMY, THE PHYSICIAN USED A COOK ACUSNARE POLYPECTOMY SNARE. THE SNARE TWISTED DURING USE. THE LOOP [SNARE HEAD] COULD BE OPENED, [BUT THEN THE SNARE HEAD] TWISTED. CATCHING THE POLYP WAS NOT POSSIBLE [BECAUSE] THE TWISTING WAS VERY STRONG. THE USER TRIED TO PULL BACK THE LOOP [SNARE HEAD] BUT IT WAS DIFFICULT [DIFFICULT RETRACTION]. THE SNARE WAS COMPLETELY REMOVED, AND THERE WAS NO PRODUCT DAMAGE OR PATIENT INJURY. THE PROCEDURE WAS COMPLETED WITH A NEW 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 Consequences Or Impact To Patient

  MAUDE report 8232271 ↗
• MalfunctionDec 27, 2018Retraction Problem; Retraction Problem

  DURING AN COLONIC ENDOSCOPIC MUCOSAL RESECTION (EMR), THE PHYSICIAN USED A COOK ACUSNARE POLYPECTOMY SNARE. THE SNARE TIP LOOPED AND THEY WERE UNABLE TO CLOSE DURING THE PROCEDURE. THERE WAS NO PATIENT HARM (SEE RELATED EMDR 1037905-2018-00608). THEY ATTEMPTED TO FINISH WITH ANOTHER DEVICE OF A DIFFERENT SIZE AND THE SAME THING HAPPENED (SUBJECT OF THIS REPORT). WHEN THAT FAILED, USED A ANOTHER MANUFACTURER'S SNARE 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 Consequences Or Impact To Patient

  MAUDE report 8199689 ↗
• MalfunctionSep 7, 2018Off-Label Use; Retraction Problem; Failure to Cut; Off-Label Use; Retraction Problem; Failure to Cut

  DURING A COLONOSCOPY, THE PHYSICIAN USED A COOK ACUSNARE POLYPECTOMY SNARE. THE SNARE WAS TWISTED WHEN COMING OUT THE PACKAGE AND WAS NOT CLOSING COMPLETELY AROUND THE POLYP. IT WOULD NOT CUT. THE DEVICE WAS USED COLD (WITHOUT CAUTERY) [AGAINST THE INTENDED USE]. 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 7855589 ↗
• MalfunctionJul 27, 2018Retraction Problem; Retraction Problem

  DURING A POLYPECTOMY PROCEDURE, THE PHYSICIAN USED A COOK ACUSNARE POLYPECTOMY SNARE. AS REPORTED TO CUSTOMER RELATIONS "THE DEVICE WOULD NOT CLOSE PROPERLY AROUND THE POLYP. IT COULD NOT SNARE THE POLYP FROM THE TISSUE. THEY WERE ABLE TO SUCCESSFULLY COMPLETE THE PROCEDURE WITH ANOTHER DEVICE. THIS HAPPENED IN THREE SEPARATE PROCEDURES WITH THREE SEPARATE PATIENTS ON THE SAME DAY WITH THE SAME LOT NUMBER." (SEE RELATED MDRS 1037905-2018-00336 AND 1037905-2018-00338 FOR THE TWO ADDITIONAL EVENTS.) THE FOLLOWING WAS RECEIVED ON 03-JULY-2018: WE HAVE HAD A RECURRING PROBLEM WITH DEFORMATION OF THE CRESCENT ACUSNARE (15 MM) [ASDB-15-015-S]. WITH A STRAIGHT ENDOSCOPE POSITION BUT A LARGE AMOUNT OF TISSUE, THE PHYSICIAN HAD TWO (2) SNARE FAILURES. ONE (1) HAD A HARD TIME CUTTING THROUGH [THE TISSUE] (1037905-2018-00336). IN THE SECOND [EVENT], THE PHYSICIAN HAD TO ABANDON AND SWITCH TO A STIFF OVAL SNARE (SUBJECT OF THIS REPORT). THE PHYSICIAN THEN HAD A THIRD PATIENT WHO EXPERIENCED THE SAME ISSUE. IT WAS FAILURE OF THE 15 MM CRESCENT SNARE [ASDB-15-015-S] TO CLOSE (SEE RELATED MDR 1037905-2018-00338). THE USER HAD TO ABANDON [THE DEVICE] AND SWITCH TO ANOTHER SNARE AFTER USING A BUNCH

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7728593 ↗
• MalfunctionJul 27, 2018Retraction Problem; Failure to Cut; Retraction Problem; Failure to Cut

  DURING A POLYPECTOMY PROCEDURE, THE PHYSICIAN USED A COOK ACUSNARE POLYPECTOMY SNARE. AS REPORTED TO CUSTOMER RELATIONS "THE DEVICE WOULD NOT CLOSE PROPERLY AROUND THE POLYP. IT COULD NOT SNARE THE POLYP FROM THE TISSUE. THEY WERE ABLE TO SUCCESSFULLY COMPLETE THE PROCEDURE WITH ANOTHER DEVICE. THIS HAPPENED IN THREE SEPARATE PROCEDURES WITH THREE SEPARATE PATIENTS ON THE SAME DAY WITH THE SAME LOT NUMBER." (SEE RELATED MDRS 1037905-2018-00337 AND 1037905-2018-00338 FOR THE TWO ADDITIONAL EVENTS) THE FOLLOWING WAS RECEIVED ON 03-JULY-2018: WE HAVE HAD A RECURRING PROBLEM WITH DEFORMATION OF THE CRESCENT ACUSNARE (15 MM) [ASDB-15-015-S]. WITH A STRAIGHT ENDOSCOPE POSITION BUT A LARGE AMOUNT OF TISSUE, THE PHYSICIAN HAD TWO (2) SNARE FAILURES. ONE (1) HAD A HARD TIME CUTTING THROUGH [THE TISSUE] (SUBJECT OF THIS REPORT). IN THE SECOND [EVENT], THE PHYSICIAN HAD TO ABANDON AND SWITCH TO A STIFF OVAL SNARE (SEE RELATED MDR 1037905-2018-00337). THE PHYSICIAN THEN HAD A THIRD PATIENT WHO EXPERIENCED THE SAME ISSUE. IT WAS FAILURE OF THE 15 MM CRESCENT SNARE [ASDB-15-015-S] TO CLOSE (SEE RELATED MDR 1037905-2018-00338). THE USER HAD TO ABANDON [THE DEVICE] AND SWITCH TO ANOTHER SNARE AFTE

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7728589 ↗