Acusnare G22700Recalls & reported problems
Cook Incorporated · Acusnare Polypectomy Snare · Class 2
All models of Acusnare (14)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 19
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 00827002227002), received between Jan 16, 2017 and Nov 11, 2025 — classified as 19 malfunctions.
The most frequently reported specific device problem is “Difficult to Open or Close” (7 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
- Difficult to Open or Close7
- Material Twisted/Bent5
- Failure to Conduct4
- Failure to Cut3
- Capturing Problem1
- Material Separation1
Patient problems
- No Clinical Signs, Symptoms or Conditions16
- Perforation2
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 19 most recent of 19 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 11, 2025Failure to Conduct; Failure to Conduct
DURING AN ENDOSCOPIC POLYPECTOMY PROCEDURE, THE PHYSICIAN USED A COOK ACUSNARE POLYPECTOMY SNARE. IT WAS REPORTED THAT THE CAUTERY DID NOT WORK. HAD TO OPEN ANOTHER PRODUCT. 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 Clinical Signs, Symptoms or Conditions
MAUDE report 23527716 ↗MalfunctionApr 2, 2025Failure to Cut; Material Twisted/Bent; Failure to Cut; Material Twisted/Bent
DURING AN UNSPECIFIED POLYPECTOMY, THE PHYSICIAN USED TWO COOK ACUSNARE POLYPECTOMY SNARE. IT WAS REPORTED [THAT] WHEN CHECKING THE SNARE WORKED WITH JUST THE TIP OUT, IT WAS OKAY BUT WHEN FULLY OPENED DURING POLYPECTOMY, THE PLASTIC COATING STARTED TO MELT AND STAFF COULD SMELL BURNING PLASTIC. CUSTOMER PROVIDED PHOTOS SHOWING THE BASE OF THE HANDLE AND THE SHEATH IS KINKED/BUCKLED ON BOTH 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 Clinical Signs, Symptoms or Conditions
MAUDE report 21752612 ↗MalfunctionMar 24, 2025Failure to Conduct; Failure to Conduct
DURING A POLYPECTOMY, THE PHYSICIAN USED A COOK ACUSNARE POLYPECTOMY SNARE. IT WAS REPORTED [THAT] AFTER THE POLYP IS [IN] ENDOSCOPIC VIEW [READY FOR] LASSOING BY SNARE THROUGH THE ENDOSCOPY, HIGH-FREQUENCY ELECTRICITY IS CONNECTED TO REMOVE THE POLYP, BUT IT COULD NOT BE ENERGIZED [SUBJECT OF REPORT], AND THE POLYP WAS EXCISED AFTER CHANGING TO ANOTHER 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 21683023 ↗MalfunctionJan 21, 2025Material Twisted/Bent; Material Twisted/Bent
DURING A COLONOSCOPY EXAMINATION, THE PHYSICIAN USED A TWO COOK ACUSNARE POLYPECTOMY SNARES. IT WAS REPORTED [THAT] PERFORATION WAS OBSERVED DURING POLYP REMOVAL. CUSTOMER PROVIDED A SNARE DIAGRAM AND INDICATED THAT TORSION WAS EXPERIENCED AT THE BASE OF SNARE AT THE TIME OF USE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT REQUIRED AN UNKNOWN ADDITIONAL PROCEDURE DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.
Patient problems: Perforation
MAUDE report 21196526 ↗MalfunctionJan 20, 2025Material Twisted/Bent; Material Twisted/Bent
DURING A COLONOSCOPY EXAMINATION, THE PHYSICIAN USED A COOK ACUSNARE POLYPECTOMY SNARE. IT WAS REPORTED [THAT] PERFORATION WAS OBSERVED DURING POLYP REMOVAL. CUSTOMER PROVIDED A SNARE DIAGRAM AND POINTS THAT TORSION WAS EXPERIENCED AT THE BASE OF SNARE AT THE TIME OF USE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT REQUIRED AN UNKNOWN ADDITIONAL PROCEDURE DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.
Patient problems: Perforation
MAUDE report 21192721 ↗MalfunctionOct 25, 2024Difficult to Open or Close; Difficult to Open or Close
DURING UNKNOWN ENDOSCOPIC PROCEDURE, THE PHYSICIAN USED A COOK ACUSNARE POLYPECTOMY SNARE. IT WAS REPORTED THAT CLOSING IS OFTEN DIFFICULT, AND THE NURSE HAS TO EXERT QUITE A BIT OF FORCE. IN THIS EVENT, POLYPS CAN BE CUT BECAUSE THE CLOSING OF THE STRING DOES NOT HAPPEN SMOOTHLY. 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 20538041 ↗MalfunctionMay 7, 2024Difficult to Open or Close; Difficult to Open or Close
DURING A COLONOSCOPY, THE PHYSICIAN USED A COOK ACUSNARE POLYPECTOMY SNARE. IT WAS INITIALLY REPORTED THAT SINCE THE CHANGE TO THE HANDLE OF THE SNARE, THE SNARE NO LONGER WORKS SMOOTHLY. OUTSIDE THE PATIENT, THE SNARE FEELS THE SAME AS USUAL, BUT IN THE SCOPE/PATIENT THE SNARE WORKS STIFFLY. BECAUSE THE SNARE IS MOVING STIFF, THE NURSE HAS LESS CONTROL AND CAN WORK LESS ACCURATELY. PREVIOUSLY, THE NURSES COULD HANDLE THE SNARE WITH THEIR EYES CLOSED, BUT SINCE THE CHANGE THEY NEED 2 HANDS TO USE THE SNARE. THERE WAS NO REPORTABLE INFORMATION AT THIS TIME. PER COMMUNICATION RECEIVED ON 12 APR 2024: IT WAS STATED THAT IT REQUIRED STRENGTH TO CLOSE [THE SNARE]. 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 19259522 ↗MalfunctionMay 7, 2024Difficult to Open or Close; Difficult to Open or Close
DURING A COLONOSCOPY, THE PHYSICIAN USED A COOK ACUSNARE POLYPECTOMY SNARE. IT WAS INITIALLY REPORTED THAT SINCE THE CHANGE TO THE HANDLE OF THE SNARE, THE SNARE NO LONGER WORKS SMOOTHLY. OUTSIDE THE PATIENT, THE SNARE FEELS THE SAME AS USUAL, BUT IN THE SCOPE/PATIENT THE SNARE WORKS STIFFLY. BECAUSE THE SNARE IS MOVING STIFF, THE NURSE HAS LESS CONTROL AND CAN WORK LESS ACCURATELY. PREVIOUSLY, THE NURSES COULD HANDLE THE SNARE WITH THEIR EYES CLOSED, BUT SINCE THE CHANGE THEY NEED 2 HANDS TO USE THE SNARE. THERE WAS NO REPORTABLE INFORMATION AT THIS TIME. PER COMMUNICATION RECEIVED ON (B)(6) 2024: IT WAS STATED THAT IT REQUIRED STRENGTH TO CLOSE [THE SNARE]. 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 19259451 ↗MalfunctionMay 7, 2024Difficult to Open or Close; Difficult to Open or Close
DURING A COLONOSCOPY, THE PHYSICIAN USED A COOK ACUSNARE POLYPECTOMY SNARE. IT WAS INITIALLY REPORTED THAT SINCE THE CHANGE TO THE HANDLE OF THE SNARE, THE SNARE NO LONGER WORKS SMOOTHLY. OUTSIDE THE PATIENT, THE SNARE FEELS THE SAME AS USUAL, BUT IN THE SCOPE/PATIENT THE SNARE WORKS STIFFLY. BECAUSE THE SNARE IS MOVING STIFF, THE NURSE HAS LESS CONTROL AND CAN WORK LESS ACCURATELY. PREVIOUSLY, THE NURSES COULD HANDLE THE SNARE WITH THEIR EYES CLOSED, BUT SINCE THE CHANGE THEY NEED 2 HANDS TO USE THE SNARE. THERE WAS NO REPORTABLE INFORMATION AT THIS TIME. PER COMMUNICATION RECEIVED ON 12 APR 2024: IT WAS STATED THAT IT REQUIRED STRENGTH TO CLOSE [THE SNARE]. 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 19259376 ↗MalfunctionApr 8, 2024Difficult to Open or Close; Difficult to Open or Close
DURING A COLON POLYPECTOMY, THE PHYSICIAN USED A COOK ACUSNARE POLYPECTOMY SNARE. IT WAS INITIALLY REPORTED THAT THE SNARE NO LONGER WORKS SMOOTHLY. OUTSIDE THE PATIENT THE SNARE FEELS THE SAME AS USUAL, BUT IN THE SCOPE/PATIENT THE SNARE WORKS STIFFLY. BECAUSE THE SNARE IS MOVING STIFF, THE NURSE HAS LESS CONTROL AND CAN WORK LESS ACCURATELY. PREVIOUSLY, THE NURSES COULD HANDLE THE SNARE WITH THEIR EYES CLOSED, BUT SINCE THE CHANGE THEY NEED 2 HANDS TO USE THE SNARE. THERE WAS NO REPORTABLE INFORMATION AT THIS TIME. ADDITIONAL INFORMATION WAS RECEIVED FROM THE USER FACILITY ON (B)(6) 2024 INDICATING THAT IT WAS DIFFICULT TO CLOSE 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 19067651 ↗MalfunctionApr 5, 2024Difficult to Open or Close; Difficult to Open or Close
DURING A COLON POLYPECTOMY, THE PHYSICIAN USED A COOK ACUSNARE POLYPECTOMY SNARE. IT WAS INITIALLY REPORTED THAT THE SNARE NO LONGER WORKS SMOOTHLY. OUTSIDE THE PATIENT THE SNARE FEELS THE SAME AS USUAL, BUT IN THE SCOPE/PATIENT THE SNARE WORKS STIFFLY. BECAUSE THE SNARE IS MOVING STIFF, THE NURSE HAS LESS CONTROL AND CAN WORK LESS ACCURATELY. PREVIOUSLY, THE NURSES COULD HANDLE THE SNARE WITH THEIR EYES CLOSED, BUT SINCE THE CHANGE THEY NEED 2 HANDS TO USE THE SNARE. THERE WAS NO REPORTABLE INFORMATION AT THIS TIME. ADDITIONAL INFORMATION WAS RECEIVED FROM THE USER FACILITY ON 13 MAR 2024 INDICATING THAT IT WAS DIFFICULT TO CLOSE 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 19052442 ↗MalfunctionApr 5, 2024Difficult to Open or Close; Difficult to Open or Close
DURING A COLON POLYPECTOMY, THE PHYSICIAN USED A COOK ACUSNARE POLYPECTOMY SNARE. IT WAS INITIALLY REPORTED THAT THE SNARE NO LONGER WORKS SMOOTHLY. OUTSIDE THE PATIENT THE SNARE FEELS THE SAME AS USUAL, BUT IN THE SCOPE/PATIENT THE SNARE WORKS STIFFLY. BECAUSE THE SNARE IS MOVING STIFF, THE NURSE HAS LESS CONTROL AND CAN WORK LESS ACCURATELY. PREVIOUSLY, THE NURSES COULD HANDLE THE SNARE WITH THEIR EYES CLOSED, BUT SINCE THE CHANGE THEY NEED 2 HANDS TO USE THE SNARE. THERE WAS NO REPORTABLE INFORMATION AT THIS TIME. ADDITIONAL INFORMATION WAS RECEIVED FROM THE USER FACILITY ON 13 MAR 2024 INDICATING THAT IT WAS DIFFICULT TO CLOSE 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 19052234 ↗MalfunctionApr 17, 2023Failure to Conduct; Failure to Conduct
DURING A POLYPECTOMY, THE PHYSICIAN USED TWO COOK ACUSNARE POLYPECTOMY SNARE. IT WAS REPORTED [THAT] THE FIRST SNARE USED DID NOT CUT. SETTINGS WERE ON "ENDO CUT." A SECOND SNARE OF THE SAME LOT NUMBER WAS OPENED. THE MEDICAL STAFF CHANGED THE ERBE ELECTROSURGICAL GENERATOR, FOOT PEDAL, CORD AND CHANGED TO SPHINCTEROTOMY SETTINGS. THE SNARE CUT A LITTLE BUT NOT AS IT SHOULD. A THIRD SNARE FROM ANOTHER MANUFACTURER WAS USED AND THE PROCEDURE COMPLETED WITH NO FURTHER COMPLICATIONS. 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 16752943 ↗MalfunctionMay 4, 2022Material Separation; Material Separation
DURING A COLONOSCOPY, THE PHYSICIAN USED A COOK ACUSNARE POLYPECTOMY SNARE. IT WAS REPORTED THAT WIRE WAS PROTRUDING FROM THE [SNARE] 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 14277797 ↗MalfunctionMar 23, 2022Material Twisted/Bent; Material Twisted/Bent
DURING A POLYPECTOMY, THE PHYSICIAN USED TWO (2) COOK ACUSNARE POLYPECTOMY SNARE. THE SNARES WERE BEING USED IN A COLONOSCOPY TO REMOVE A 5CM PEDUNCULATED POLYP. WHEN THE POLYPECTOMY WAS ATTEMPTED WITH THE FIRST SNARE, THE SNARE WOULD NOT CUT THROUGH THE POLYP WITH CAUTERY. THEY THEN SWITCHED SNARES TO THE SECOND SNARE FROM THE SAME LOT NUMBER AND ENCOUNTERED THE SAME ISSUE. THEY SWITCHED CAUTERY MACHINES BUT THAT MADE NO DIFFERENCE. THEY SWITCHED TO A THIRD SNARE OF A DIFFERENT LOT NUMBER, AND WERE ABLE TO FINISH THE PROCEDURE. THE PROXIMAL END OF THE CATHETER ON BOTH SNARES, NEXT TO THE HANDLE, ARE CRUMPLED UP. 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 13861855 ↗MalfunctionJan 13, 2022Capturing Problem; Capturing Problem
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 13250462 ↗MalfunctionAug 18, 2021Material Twisted/Bent; Material Twisted/Bent
DURING A POLYPECTOMY PROCEDURE, THE PHYSICIAN USED A COOK ACUSNARE POLYPECTOMY SNARE. THE SNARE BUCKLED THE PLASTIC AT THE TOP BY THE HANDLE AND IS NOT CUTTING THROUGH POLYPS WELL. 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 12335720 ↗MalfunctionJun 15, 2021Failure to Cut; Failure to Cut
DURING A POLYPECTOMY PROCEDURE, THE PHYSICIAN USED AN ACUSNARE POLYPECTOMY SNARE. THE SNARE WOULD NOT CUT THROUGH 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 11999132 ↗MalfunctionJan 16, 2017Failure to Conduct; Failure to Cut; Failure to Conduct; Failure to Cut
THE FOLLOWING WAS INITIALLY REPORTED TO THE FDA ON (B)(6) 2017: "DURING A COLONOSCOPY PROCEDURE, THE PHYSICIAN USED A COOK ACUSNARE POLYPECTOMY SNARE (ASH-1-S). AS REPORTED TO CUSTOMER RELATIONS: "TODAY THE PHYSICIAN USED THE ASH-1-S SNARE. THE PHYSICIAN WAS ABLE TO GET IT AROUND THE POLYP/TUMOR BUT IT WOULD NOT RELEASE NOR CUT/COAGULATE. THE PHYSICIAN FINALLY HAD TO "TUG¿ FAIRLY HARD BECAUSE IT [THE SNARE] WAS HARD TO GET IT OUT. SEVERAL PLACES LOOKED LIKE IT WAS TWISTED.¿ A MEDWATCH REPORT MW5073227 WAS RECEIVED ON 11/28/2017: "SNARE WOULD NOT RELEASE POLYP FROM TUMOR/POLYP DURING COLONOSCOPY. THE POLYP WAS SNARED, CLOSED, COAG [COAGULATION] SET AT 18, SNARE WOULD NOT RELEASE OR CUT THROUGH. NO HARM TO PATIENT WAS NOTED. DIAGNOSIS OR REASON FOR USE: COLONOSCOPY, RECTAL MASS."
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6254395 ↗
Other Unit, electrosurgical, endoscopic (with or without accessories) devices
- THUNDERBEAT 5 mm, 35 cm, Front-actuated Grip TB-0535FCOlympus Medical Systems Corp. · Unit, electrosurgical, endoscopic (with or without accessories)1 recall2 deaths404 reports
- SONICBEAT 5 mm, 35 cm, Front-actuated Grip SB-0535FCOlympus Medical Systems Corp. · Unit, electrosurgical, endoscopic (with or without accessories)379 reports
- Single Use Electrosurgical Knife KD-611LOlympus Medical Systems Corp. · Unit, electrosurgical, endoscopic (with or without accessories)1 death357 reports
- Autotome™ RX 44 M00545170Boston Scientific Corporation · Unit, electrosurgical, endoscopic (with or without accessories)1 recall262 reports
- TRUEtome 44 M00584170Boston Scientific Corporation · Unit, electrosurgical, endoscopic (with or without accessories)237 reports
- Dreamtome™ RX 44 M00584040Boston Scientific Corporation · Unit, electrosurgical, endoscopic (with or without accessories)1 recall165 reports
- Dreamtome™ RX 44 M00584050Boston Scientific Corporation · Unit, electrosurgical, endoscopic (with or without accessories)1 recall127 reports
- Single Use 3-Lumen Sphincterotome V KD-V411M-0725Olympus Medical Systems Corp. · Unit, electrosurgical, endoscopic (with or without accessories)160 reports
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.
How reports and recalls are matched · Editorial policy · Report an error on this page