Acusnare G22649Recalls & reported problems

Summary

The FDA's MAUDE database contains 39 adverse event reports that list this exact device (DI 00827002226494), received between Jul 29, 2016 and Sep 11, 2026 — classified as 6 injuries, 33 malfunctions.

The most frequently reported specific device problem is “Retraction Problem” (27 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 25 most recent of 39 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 11, 2026Difficult to Open or Close

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50738189 ↗
• InjuryOct 31, 2025Failure to Cut; Failure to Cut

  DURING AN ENDOSCOPIC POLYPECTOMY PROCEDURE FOR A SEMI SESSILE COLON POLYP IN THE ASCENDING COLON, THE PHYSICIAN USED A COOK ACUSNARE POLYPECTOMY SNARE. THEY REPORTED THAT POLYP WAS APPROXIMATELY 1 CM IN SIZE. THE DEVICE WAS CONNECTED TO AN ERBE DEVICE THE DEVICE DID HAVE ELECTRICITY INITIALLY WHEN COAGULATING/BURNING BY LOST ELECTRICITY MIDWAY THROUGH BURNING BEFORE CUT WAS INITIATED. THERE WAS SOME TISSUE DAMAGE FROM THE SNARE GETTING STUCK AROUND THE POLYP WITHOUT ANY WATTS GOING THROUGH. THEY WERE ABLE TO FREE THE TISSUE AND CHANGE OUT THE SNARE FOR A DIFFERENT TYPE AND HAD NO FURTHER ISSUES. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE AREA WAS CAUTERIZED WITH ANOTHER DEVICE AND AN INSTINCT PLUS ENDOSCOPIC CLIPPING DEVICE WAS PLACED DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: Gastrointestinal Hemorrhage

  MAUDE report 23442059 ↗
• MalfunctionOct 31, 2025Failure to Conduct; Failure to Conduct

  DURING AN ENDOSCOPIC POLYPECTOMY PROCEDURE FOR A PEDUNCULATED COLON POLYP IN THE LEFT COLON, THE PHYSICIAN USED A COOK ACUSNARE POLYPECTOMY SNARE. THEY REPORTED THAT THE DEVICE WAS CONNECTED TO THE ERBE DEVICE BUT IT DID NOT CUT/COAGULATE DESPITE THE MACHINE REGISTERING THAT IT WAS ACTIVE. WE SWITCHED OUT THE SNARE FOR ANOTHER OF THE SAME TYPE AND WE HAD NO ISSUES WITH THE SECOND 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 23442036 ↗
• MalfunctionJan 9, 2024Failure to Cut; Failure to Cut

  DURING A COLONOSCOPY WITH POLYPECTOMY, THE PHYSICIAN USED A COOK ACUSNARE POLYPECTOMY SNARE. IT WAS REPORTED [THAT] THEY HOOKED IT UP TO CAUTERY TO REMOVE THE POLYP. WHEN USING CAUTERY, THE HANDLE BEGAN TO BURN AND MELT WHERE THE PLASTIC PART YOU PUT IN THE SCOPE MEETS THE HANDLE. THE SNARE THEN GOT STUCK TO THE POLYP AND THEY COULD NOT GET THE POLYP OFF THE SNARE. THEY SOMEHOW REMOVED THE DEVICE FROM THE PATIENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER DEVICE OF THE SAME TYPE. THIS PROBLEM OCCURRED ONCE WITH ONE PATIENT ON (B)(6) 2023 [SUBJECT OF REPORT] AND AGAIN WITH A DIFFERENT PATIENT ON (B)(6) 2023 [CAPTURED IN SEPARATE REPORT]. NO ONE WAS HARMED BY THE HOT HANDLE IN EITHER 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 18474410 ↗
• MalfunctionJan 9, 2024Failure to Cut; Failure to Cut

  DURING A COLONOSCOPY WITH POLYPECTOMY, THE PHYSICIAN USED A COOK ACUSNARE POLYPECTOMY SNARE. IT WAS REPORTED [THAT] THEY HOOKED IT UP TO CAUTERY TO REMOVE THE POLYP. WHEN USING CAUTERY, THE HANDLE BEGAN TO BURN AND MELT WHERE THE PLASTIC PART YOU PUT IN THE SCOPE MEETS THE HANDLE. THE SNARE THEN GOT STUCK TO THE POLYP AND THEY COULD NOT GET THE POLYP OFF THE SNARE. THEY SOMEHOW REMOVED THE DEVICE FROM THE PATIENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER DEVICE OF THE SAME TYPE. THIS PROBLEM OCCURRED ONCE WITH ONE PATIENT ON (B)(6) 2023 [CAPTURED IN SEPARATE REPORTS] AND AGAIN WITH A DIFFERENT PATIENT ON (B)(6) 2023 [SUBJECT OF REPORT]. NO ONE WAS HARMED BY THE HOT HANDLE IN EITHER 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 18474407 ↗
• MalfunctionDec 5, 2022Material Deformation; Material Deformation

  IN PREPARATION FOR A PROCEDURE, THE USER SELECTED A COOK ACUSNARE POLYPECTOMY SNARE. IT WAS REPORTED [THAT THE] ACUSNARE WAS BENT WHEN REMOVED FROM PACKAGE. [SNARE] WAS NOT USED. OPENED A NEW SNARE OF THE SAME TYPE TO FINISH PROCEDURE. THERE WAS NO REPORTABLE INFORMATION AT THIS TIME. THE DEVICE WAS EVALUATED ON 11/09/2022. DURING THE EVALUATION IT WAS NOTED THAT THE SNARE WAS DEFORMED AND PARTIALLY ADVANCED. THE SNARE WOULD NOT FULLY RETRACT DUE TO THE DEFORMITY. THIS OCCURRED PRIOR TO PATIENT CONTACT; THERE WAS NO IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15915332 ↗
• MalfunctionApr 20, 2021Failure to Advance; Failure to Advance

  DURING A ESOPHAGOGASTRODUODENOSCOPY WITH CLEANING OUT OF PANCREATIC PSEUDOCYST , THE PHYSICIAN USED A COOK ACUSNARE POLYPECTOMY SNARE. IT WAS INITIALLY REPORTED THAT THE SNARE WIRE WOULD NOT COME OUT OF THE SHEATH WHEN THEY DID THE SECOND PASS WITH THE DEVICE. HERE WAS NO REPORTABLE INFORMATION AT THIS TIME. OUR EVALUATION OF THE RETURNED DEVICE ON (B)(6) 2021, DETERMINED THAT THE SNARE WAS ADVANCED FROM THE SHEATH BUT WOULD NOT FULLY RETRACT WHEN HANDLE WAS MANIPULATED [SUBJECT OF THE 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 11693418 ↗
• MalfunctionFeb 24, 2021Failure to Conduct; Failure to Conduct

  DURING A COLONOSCOPY, THE PHYSICIAN USED AN ACUSNARE POLYPECTOMY SNARE. THE PLASTIC SHEATH CURLED UP BY THE HANDLE AND COULD NOT ACTIVATE [THE DEVICE]. 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 11372087 ↗
• MalfunctionOct 14, 2020Retraction Problem; Retraction Problem

  DURING AN ENDOSCOPIC PROCEDURE TO REMOVE A POLYP, THE PHYSICIAN USED AN ACUSNARE POLYPECTOMY SNARE. THE DEVICE WAS OPENED AND PLACED DOWN THE ENDOSCOPE. WHEN THE USER OPENED UP THE SNARE, THE USER NOTED THAT THE TIP WAS BENT AND SUBSEQUENTLY THE SNARE WOULD NOT FULLY RETRACT [SUBJECT OF REPORT]. THE USER REMOVED THE ENTIRE DEVICE AND SET IT ASIDE. 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 10678967 ↗
• MalfunctionAug 27, 2020Failure to Cut; Failure to Cut

  DURING A COLONOSCOPY, THE PHYSICIAN USED A ACUSNARE POLYPECTOMY SNARE. THE SNARE WAS HARD TO OPEN. THE DEVICE WAS NOT CUTTING PROPERLY WITH CAUTERY AND THE TIP OF THE SNARE BECAME STUCK ON THE POLYP WHICH REQUIRED TUGGING AND PULLING [SUBJECT OF REPORT]. THE DEVICE WAS ABLE TO BE REMOVED FROM THE POLYP AND THE PATIENT'S BODY. THERE WAS NO HARM TO THE PATIENT. 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 10461499 ↗
• MalfunctionFeb 8, 2019Failure to Conduct; Failure to Conduct

  DURING A COLONOSCOPY, THE PHYSICIAN USED A COOK ACUSNARE POLYPECTOMY SNARE. THE SNARE DID NOT WORK WHEN USED. PER A VERBAL DISCUSSION WITH THE COOK DISTRICT MANAGER ON 15-JAN-2019: THE DEVICE MISFIRED. HAD A MEETING SET UP WITH THE FACILITY TO DISCUSS. PER CUSTOMER'S PROVIDED INFORMATION ON 15-JAN-2019: THE SNARE DEPLOYED FOR POLYPECTOMY, BUT THERE WAS NO ELECTRICAL CURRENT TO THE SNARE (SUBJECT OF THIS REPORT). THE USER CHECKED ALL THE WIRING AND EQUIPMENT; THEN USED DIFFERENT TYPE OF SNARE WHICH WORKED FINE. 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 8321370 ↗
• 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 (SUBJECT OF THIS REPORT). THEY ATTEMPTED TO FINISH WITH ANOTHER DEVICE OF A DIFFERENT SIZE AND THE SAME THING HAPPENED (SEE RELATED EMDR 1037905-2018-00609). 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 8199693 ↗
• MalfunctionDec 12, 2018Retraction Problem; Retraction Problem

  DURING A COLONOSCOPY, THE PHYSICIAN USED A COOK ACUSNARE POLYPECTOMY SNARE. THE DEVICE OPENED BUT WOULD NOT CLOSE [RETRACT] COMPLETELY. THIS OCCURRED WITH TWO (2) DEVICES, FROM DIFFERENT LOTS, DURING THE SAME PROCEDURE (SEE RELATED MDR 1037905-2018-00583). THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER 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 Consequences Or Impact To Patient

  MAUDE report 8156177 ↗
• MalfunctionDec 12, 2018Retraction Problem; Retraction Problem

  DURING A COLONOSCOPY, THE PHYSICIAN USED A COOK ACUSNARE POLYPECTOMY SNARE. THE DEVICE OPENED BUT WOULD NOT CLOSE [RETRACT] COMPLETELY. THIS OCCURRED WITH TWO (2) DEVICES, FROM DIFFERENT LOTS, DURING THE SAME PROCEDURE (SEE RELATED MDR 1037905-2018-00582). THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER 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 Consequences Or Impact To Patient

  MAUDE report 8156089 ↗
• InjuryNov 29, 2018Retraction Problem; Retraction Problem

  DURING A ENDOSCOPIC MUCOSAL RESECTION (EMR), THE PHYSICIAN USED A COOK ACUSNARE POLYPECTOMY SNARE. AS REPORTED TO CUSTOMER RELATIONS BY THE CUSTOMER, "THE SNARE WIRE CROSSED DURING A PROCEDURE AND THEY WERE UNABLE TO FULLY CLOSE. THEY HAD TO PULL IT OUT OF THE PATIENT. IT LOOKS TANGLED." THE FOLLOWING WAS RECEIVED ON 11/28/2018: EMR WAS PERFORMED, AND THE SNARE WAS USED BY EXPERIENCED STAFF. UPON RETRACTION, THE SNARE HEAD BECAME TANGLED AND IT WAS UNABLE TO CLOSE COMPLETELY. A PERFORATION OCCURRED AS A RESULT. HEMOSTASIS CLIPS WERE PLACED AND THE PATIENT WAS ADMITTED FOR A HOSPITAL STAY. DURING THE HOSPITAL STAY, A THREE-VIEW X-RAY WAS PERFORMED AND CONFIRMED FREE AIR, CONSISTENT WITH A PERFORATION. A REPEAT COLONOSCOPY WAS PERFORMED TO REPAIR THE PERFORATION WITH [ADDITIONAL] HEMOSTASIS CLIPS. THIS OCCURRED ON THREE PATIENTS. SEE RELATED MDRS 1037905-2018-00553 AND 1037905-2018-00554 (TO BE SUBMITTED BY 28-DEC-2018). A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT REQUIRED PLACEMENT OF HEMOSTASIS CLIPS, HOSPITALIZATION AND A REPEAT COLONOSCOPY TO PLACE ADDITIONAL HEMOSTASIS CLIPS TO REPAIR THE PERFORATION DUE TO THIS OCCURRENCE. ACCORDING TO THE INIT

  Patient problems: Perforation

  MAUDE report 8115567 ↗
• InjuryNov 29, 2018Retraction Problem; Retraction Problem

  DURING A ENDOSCOPIC MUCOSAL RESECTION (EMR), THE PHYSICIAN USED A COOK ACUSNARE POLYPECTOMY SNARE. AS REPORTED TO CUSTOMER RELATIONS BY THE CUSTOMER, "THE SNARE WIRE CROSSED DURING A PROCEDURE AND THEY WERE UNABLE TO FULLY CLOSE. THEY HAD TO PULL IT OUT OF THE PATIENT. IT LOOKS TANGLED." THE FOLLOWING WAS RECEIVED ON 11/28/2018: EMR WAS PERFORMED, AND THE SNARE WAS USED BY EXPERIENCED STAFF. UPON RETRACTION, THE SNARE HEAD BECAME TANGLED AND IT WAS UNABLE TO CLOSE COMPLETELY. A PERFORATION OCCURRED AS A RESULT. HEMOSTASIS CLIPS WERE PLACED AND THE PATIENT WAS ADMITTED FOR A HOSPITAL STAY. DURING THE HOSPITAL STAY, A THREE-VIEW X-RAY WAS PERFORMED AND CONFIRMED FREE AIR, CONSISTENT WITH A PERFORATION. A REPEAT COLONOSCOPY WAS PERFORMED TO REPAIR THE PERFORATION WITH [ADDITIONAL] HEMOSTASIS CLIPS. THIS OCCURRED ON THREE PATIENTS. SEE RELATED MDRS 1037905-2018-00552 AND 1037905-2018-00554. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT REQUIRED PLACEMENT OF HEMOSTASIS CLIPS, HOSPITALIZATION AND A REPEAT COLONOSCOPY TO PLACE ADDITIONAL HEMOSTASIS CLIPS TO REPAIR THE PERFORATION DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT

  Patient problems: Perforation

  MAUDE report 8115564 ↗
• MalfunctionSep 28, 2018Retraction Problem; Retraction Problem

  DURING A POLYPECTOMY, THE PHYSICIAN USED A COOK ACUSNARE POLYPECTOMY SNARE. AFTER ONE USE OF THE SNARE, THE SNARE DEFORMED. MOST OF THE TIME THE USER CANNOT RETRACT THE SNARE INTO THE SHEATH. BECAUSE OF THIS DEFORMITY, [THE SNARE] CAN ONLY BE USED ONCE [FOR ONE POLYP] AND DOES NOT CUT ALL THE WAY THROUGH BECAUSE THE SNARE CANNOT RETRACT FULLY THROUGH THE POLYP. SEE RELATED MDRS 1037905-2018-00457, 1037905-2018-00459, AND 1037905-2018-00460. 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 7918856 ↗
• MalfunctionSep 28, 2018Retraction Problem; Retraction Problem

  DURING A POLYPECTOMY, THE PHYSICIAN USED TWO (2) COOK ACUSNARE POLYPECTOMY SNARES. AFTER ONE USE OF THE SNARES, THE SNARES DEFORMED. MOST OF THE TIME THE USER CANNOT RETRACT THE SNARES INTO THE SHEATH. BECAUSE OF THIS DEFORMITY, [THE SNARES] CAN ONLY BE USED ONCE [FOR ONE POLYP] AND DO NOT CUT ALL THE WAY THROUGH BECAUSE THE SNARES CANNOT RETRACT FULLY THROUGH THE POLYP. SEE RELATED MDRS 1037905-2018-00457, 1037905-2018-00458, AND 1037905-2018-00459. A SECTION OF THE DEVICES 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 7918850 ↗
• MalfunctionSep 28, 2018Retraction Problem; Retraction Problem

  DURING A POLYPECTOMY, THE PHYSICIAN USED A COOK ACUSNARE POLYPECTOMY SNARE. AFTER ONE USE OF THE SNARE, THE SNARE DEFORMED. MOST OF THE TIME THE USER CANNOT RETRACT THE SNARE INTO THE SHEATH. BECAUSE OF THIS DEFORMITY, [THE SNARE] CAN ONLY BE USED ONCE [FOR ONE POLYP] AND DOES NOT CUT ALL THE WAY THROUGH BECAUSE THE SNARE CANNOT RETRACT FULLY THROUGH THE POLYP. SEE RELATED MDRS 1037905-2018-00457, 1037905-2018-00458, AND 1037905-2018-00460. 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 7918845 ↗
• MalfunctionSep 28, 2018Retraction Problem; Retraction Problem

  DURING AN ENDOSCOPIC MUCOSAL RESECTION (EMR), THE PHYSICIAN USED A COOK ACUSNARE POLYPECTOMY SNARE. THE SNARE WOULD NOT CLOSE ALL OF THE WAY. THE SNARE WAS TESTED PRIOR TO INSERTING INTO THE ENDOSCOPE, AND VISUALLY APPEARED TO WORK CORRECTLY. THE PHYSICIAN WAS ABLE TO RESECT THE TISSUE USING THE ORIGINAL SNARE AND CAUTERY [INTENDED PROCEDURE] EVEN THOUGH IT WOULD NOT CLOSE 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 Consequences Or Impact To Patient

  MAUDE report 7918826 ↗
• MalfunctionSep 28, 2018Retraction Problem; Retraction Problem

  DURING A POLYPECTOMY, THE PHYSICIAN USED A COOK ACUSNARE POLYPECTOMY SNARE. AFTER ONE USE OF THE SNARE, THE SNARE DEFORMED. MOST OF THE TIME THE USER CANNOT RETRACT THE SNARE INTO THE SHEATH. BECAUSE OF THIS DEFORMITY, [THE SNARE] CAN ONLY BE USED ONCE [FOR ONE POLYP] AND DOES NOT CUT ALL THE WAY THROUGH BECAUSE THE SNARE CANNOT RETRACT FULLY THROUGH THE POLYP. SEE RELATED MDRS 1037905-2018-00458, 1037905-2018-00459, AND 1037905-2018-00460. 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 7918814 ↗
• InjurySep 28, 2018Retraction Problem; Retraction Problem

  DURING AN ENDOSCOPIC MUCOSAL RESECTION (EMR), THE PHYSICIAN USED A COOK ACUSNARE POLYPECTOMY SNARE. THE SNARE WOULD NOT CLOSE ALL OF THE WAY. THE SNARE WAS TESTED PRIOR TO INSERTING IT INTO THE ENDOSCOPE AND VISUALLY APPEARED TO WORK CORRECTLY. THE PHYSICIAN WAS ABLE TO RESECT THE TISSUE USING THE ORIGINAL SNARE AND CAUTERY [INTENDED PROCEDURE] EVEN THOUGH IT WOULD NOT CLOSE PROPERLY. AFTER RESECTION AND INSPECTION OF THE TISSUE , THE PHYSICIAN NOTICED THE PERFORATION. THE PHYSICIAN STATED THE SNARE WOULD NOT CLOSE ALL OF THE WAY, WHICH CAUSED A PERFORATION. THE PHYSICIAN REPAIRED THE PERFORATION BY USING ENDOSCOPIC CLIPS IN A ZIPPER FASHION. THE COOK SALES REPRESENTATIVE STATED THE FOLLOWING ON (B)(4) 2018: "I CONTACTED THE PHYSICIAN AND THE RESPONSE WAS THAT HE CANNOT BE CERTAIN THE DEVICE CAUSED THE PERFORATION VERSUS ATTRIBUTING IT TO THE RISK OF THE PROCEDURE. HE SAID THEY DO OVER 250 COLON EMRS PER YEAR, MOSTLY USING THE COOK DUCKBILL SNARES, AND DO NOT HAVE MANY ISSUES." A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. ENDOSCOPIC CLIPS WERE USED TO REPAIR A PERFORATION DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT WAS ADMITTED TO THE

  Patient problems: Perforation

  MAUDE report 7918705 ↗
• InjurySep 24, 2018Retraction Problem; Retraction Problem

  DURING A COLONOSCOPIC RESECTION OF A POLYP, THE PHYSICIAN USED A COOK ACUSNARE POLYPECTOMY SNARE. THE DEVICE STUCK TO THE TISSUE AND WAS UNABLE TO COMPLETE FULL RESECTION OF THE POLYP. THE DEVICE WAS REMOVED. THERE WAS BLEEDING. FURTHER INFORMATION WAS RECEIVED BY COOK PRODUCT MANAGEMENT ON 30-AUGUST-2018: "[THE PHYSICIAN] HAD A MAJOR MALFUNCTION DURING RESECTION OF A POLYP WITH A 25 MM COOK DUCKBILL ACUSNARE. I BELIEVE THIS WAS IN THE COLON. THIS MALFUNCTION RESULTED IN A SERIOUS ADVERSE EVENT - BLEEDING." THE FOLLOWING WAS RECEIVED ON 17-SEPTEMBER-2018: THE BLEEDING WAS STOPPED WITH ANOTHER MANUFACTURER'S HEMOSTASIS CLIP. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. A HEMOSTASIS CLIP WAS USED DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT EXPERIENCED BLEEDING DUE TO THIS OCCURRENCE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Hemostasis

  MAUDE report 7901814 ↗
• MalfunctionSep 7, 2018Retraction Problem; Use of Device Problem; Retraction Problem; Use of Device Problem

  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. 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 7855588 ↗
• MalfunctionSep 7, 2018Retraction Problem; Use of Device Problem; Retraction Problem; Use of Device Problem

  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. 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 7855587 ↗