Acusnare G22629Recalls & reported problems

Summary

The FDA's MAUDE database contains 35 adverse event reports that list this exact device (DI 00827002226296), received between Jan 13, 2017 and Jun 8, 2026 — classified as 6 injuries, 29 malfunctions.

The most frequently reported specific device problem is “Failure to Conduct” (12 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 35 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 8, 2026Difficult to Fold, Unfold or Collapse; Failure to Cut

  DURING AN ENDOSCOPIC PROCEDURE, THE PHYSICIAN USED AN ACUSNARE POLYPECTOMY SNARE. IT WAS REPORTED THAT THE SNARE WOULD NOT CUT. 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 25430870 ↗
• MalfunctionMar 31, 2026Failure to Conduct

  DURING A COLONOSCOPY, THE PHYSICIAN USED A COOK ACUSNARE POLYPECTOMY SNARE. IT WAS REPORTED [THAT] THE DEVICE WAS ENERGIZED IN PREPARATION FOR POLYP LIGATION, BUT IT FAILED TO ACTIVATE. THE DEVICE WAS RETRACTED, A NEW AS-1-S WAS INTRODUCED, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY.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 Clinical Signs, Symptoms or Conditions

  MAUDE report 24743645 ↗
• MalfunctionSep 3, 2025Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  IN PREPARATION FOR A PROCEDURE, THE USER SELECTED A COOK ACUSNARE POLYPECTOMY SNARE. IT WAS REPORTED [THAT THE] USER OPENED THE PACKAGE AND FOUND THAT THE STEEL WIRE AT THE HANDLE WAS EXPOSED, SO [USER] REPLACED [DEVICE] WITH A NEW PRODUCT TO COMPLETE THE PROCEDURE. THIS OCCURRED PRIOR TO PATIENT CONTACT; THERE WAS NO IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22955540 ↗
• InjuryApr 29, 2025Failure to Cut; Failure to Cut

  DURING AN UNKNOWN ENDOSCOPIC PROCEDURE, THE PHYSICIAN USED A COOK ACUSNARE POLYPECTOMY SNARE. IT WAS REPORTED [THAT] ON THE FIRST POLYP THAT THE SNARE WAS USED ON, THERE WAS NOT A PROBLEM. HOWEVER, ON THE SECOND POLYP THAT IT WAS USED ON, IT RIPPED THE COLONIC MUCOSA APPROXIMATELY A CM IN LENGTH. UPON REMOVING THE SNARE, IT WAS NOTED THAT THE LOOP FELT UNUSUALLY ROUGH AND ABRASIVE. THE POLYP WAS SUCCESSFULLY REMOVED. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT REQUIRED THE AFFECTED MUCOSAL AREA OF INJURY TO BE CLIPPED WITH 2 LARGE CLIPS TO CLOSE THE DEFECT DUE TO THIS OCCURRENCE.

  Patient problems: Gastrointestinal Hemorrhage

  MAUDE report 21930010 ↗
• MalfunctionJan 20, 2025Material Separation; Material Separation

  DURING A POLYPECTOMY, THE PHYSICIAN USED A COOK ACUSNARE POLYPECTOMY SNARE. IT WAS REPORTED [THAT] THE HANDLE CONJUNCTION AREA DETACHED. USER CHANGED TO A NEW DEVICE TO COMPLETE THE PROCEDURE. CUSTOMER PROVIDED PHOTO THAT SHOWS THE DEVICE IN A COILED POSITION AND THE HANDLE CANNULA IS SEEN ADVANCED INTO THE CATHETER, INDICATING SEPARATION IN THE HANDLE. THE SECOND PHOTO SHOWS THE DEVICE IN A COILED POSITION, AND THE HANDLE CANNULA IS ADVANCED EVEN FARTHER INTO THE CATHETER. 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 21193152 ↗
• MalfunctionApr 12, 2024Failure to Cut; Failure to Cut

  DURING A POLYPECTOMY IN THE COLON, 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 NOT WORKING SMOOTH, THE NURSE HAS LESS CONTROL AND CAN¿T WORK LESS ACCURATELY. PREVIOUSLY, NURSES COULD WORK WITH THE SNARE WITH THEIR EYES CLOSED, BUT SINCE THE CHANGE THEY NEED 2 HANDS TO HANDLE THE SNARE. THIS WAS INITIALLY CONSIDERED TO BE USER PREFERENCE AND WAS NOT REPORTABLE. ADDITIONAL INFORMATION WAS RECEIVED ON 20 MAR 2024 STATING THAT IT LOOKS LIKE THE CUTTING IS NOT WORKING PROPERLY WHICH IS REPORTABLE. 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 19101310 ↗
• MalfunctionApr 12, 2024Difficult to Open or Close; Difficult to Open or Close

  DURING A POLYPECTOMY IN THE COLON, 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 NOT WORKING SMOOTH, THE NURSE HAS LESS CONTROL AND CAN¿T WORK LESS ACCURATELY. PREVIOUSLY, NURSES COULD WORK WITH THE SNARE WITH THEIR EYES CLOSED, BUT SINCE THE CHANGE THEY NEED 2 HANDS TO HANDLE THE SNARE. THIS WAS INITIALLY CONSIDERED TO BE USER PREFERENCE AND WAS NOT REPORTABLE. ON 20 MAR 2024, WE RECEIVED ADDITIONAL INFORMATION STATING THAT IT WAS DIFFICULT TO CLOSE THE SNARE. THIS IS CONSIDERED REPORTABLE FOR DIFFICULTY RETRACTING THE SNARE HEAD. 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 19100577 ↗
• MalfunctionMar 29, 2024Retraction Problem; Deformation Due to Compressive Stress; Retraction Problem; Deformation Due to Compressive Stress

  IN PREPARATION FOR A PROCEDURE, THE USER SELECTED A COOK ACUSNARE POLYPECTOMY SNARE. IT WAS REPORTED THAT THE USER OPENED THE PACKAGE AND DISCOVERED THE WIRE CORE NEAR THE HANDLE WAS BROKEN. IT WAS NOT USED ON THE PATIENT. THIS OCCURRED PRIOR TO PATIENT CONTACT; THERE WAS NO IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19003077 ↗
• MalfunctionMar 25, 2024Failure to Cut; Failure to Cut

  DURING A COLONOSCOPY, THE PHYSICIAN USED A COOK ACUSNARE POLYPECTOMY SNARE. IT WAS REPORTED [THAT] THE SNARE WOULD NOT CUT THE POLYP EVEN WITH THE CAUTERIZATION ON. PROCEDURE WAS COMPLETED BY THE USER PULLING OUT THE DEVICE ALONG WITH THE POLYP. NO HARM TO 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 18970519 ↗
• MalfunctionMar 25, 2024Failure to Cut; Failure to Cut

  DURING A COLONOSCOPY, THE PHYSICIAN USED A COOK ACUSNARE POLYPECTOMY SNARE. IT WAS REPORTED [THAT] THE SNARE WOULD NOT CUT THE POLYP EVEN WITH THE CAUTERIZATION ON. PROCEDURE WAS COMPLETED BY THE USER PULLING OUT THE DEVICE ALONG WITH THE POLYP. NO HARM TO 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 18970517 ↗
• InjuryDec 20, 2023Retraction Problem; Retraction Problem

  DURING A COLONIC POLYP ABLATION, THE PHYSICIAN USED A COOK ACUSNARE POLYPECTOMY SNARE. IT WAS REPORTED [THAT] THE NOOSE [SNARE LOOP] COULD NOT BE COMPLETELY TIGHTENED. ELECTRICITY MUST BE USED MORE OFTEN. THE MINIMAL RESIDUAL TISSUE STALK COULD NOT BE SEVERED WITH THE SNARE. THIS WAS FINALLY ACHIEVED WITH A LOT OF MANIPULATION AND SUBSEQUENT BLEEDING. THE DOCTOR SAID THE POLYP WAS NORMAL AND NOT PARTICULARLY LARGE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT REQUIRED HEMOSTASIS. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: Gastrointestinal Hemorrhage

  MAUDE report 18365667 ↗
• MalfunctionDec 18, 2023Failure to Conduct; Failure to Conduct

  DURING AN UNKNOWN ENDOSCOPIC PROCEDURE, THE PHYSICIAN USED A COOK ACUSNARE POLYPECTOMY SNARE. IT WAS REPORTED [THAT THE] USER ADVANCED DEVICE INTO PATIENT TO THE TARGET AREA AND CAPTURED THE POLYP, BUT FOUND OUT THERE IS NO ELECTRICITY WITH POWER ON. USER THEN CHANGED TO A SIMILAR 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 18348441 ↗
• MalfunctionJul 25, 2023Failure to Cut; Failure to Cut

  DURING A POLYPECTOMY IN THE COLON, THE PHYSICIAN USED A COOK ACUSNARE POLYPECTOMY SNARE. IT WAS REPORTED [THAT THE] POLYPECTOMY HANDLE WHICH AT THE TIME OF ENSURING THE LESION DOES NOT GENERATE A CUT, CONNECTIONS OF THE ELECTROSURGICAL UNIT ARE REVIEWED AND ARE COUPLED, FUNCTION FOR ACTIVE CUTTING AND COAGULATION [CONNECTIONS/ACCESSORIES WORKING]. 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 17390567 ↗
• MalfunctionDec 5, 2022Nonstandard Device; Material Separation; Nonstandard Device; Material Separation

  DURING AN UNKNOWN PROCEDURE, THE PHYSICIAN USED A COOK ACUSNARE POLYPECTOMY SNARE. IT WAS REPORTED [THAT] THE LIS [SNARE HEAD LOOP] DOES NOT WANT TO UNFOLD [ADVANCE]. THE [DRIVE] WIRE IS NOT CORRECTLY ATTACHED TO THE HANDLE. THIS IS INTERPRETED TO MEAN THAT THE HANDLE CANNULA SEPARATED FROM 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 INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15920758 ↗
• MalfunctionOct 25, 2022Failure to Cut; Failure to Cut

  DURING A COLON MUCOSECTOMY , THE PHYSICIAN USED A COOK ACUSNARE POLYPECTOMY SNARE. IT WAS REPORTED [THAT] WHEN TRYING TO PERFORM THE PROCEDURE WITH ELECTRIC CURRENT, THE MATERIAL DID NOT CUT. HOWEVER, THE DEVICE WAS REPLACED AND THE PROCEDURE WAS COMPLETED. 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 15668326 ↗
• InjuryMay 24, 2022Failure to Conduct; Failure to Conduct

  DURING A POLYPECTOMY PROCEDURE, THE PHYSICIAN USED A ACUSNARE POLYPECTOMY SNARE. IT WAS REPORTED THE SNARE COULD NOT GET ANY ELECTRICITY, THE SAME MALFUNCTION OCCURRED IN TWO OTHER PROCEDURES CAPTURED IN A SEPARATE REPORT (SEE COOK REFERENCE (B)(4)). THE PHYSICIAN MADE A FULL REVISION [REPAIR & SERVICE] OF THE COAGULATION MACHINE AND ACTIVE CORD AS WELL AFTER THESE INCIDENTS. FOR THE PROCEDURE ON (B)(6) 2022 (SUBJECT OF THIS REPORT), THE PHYSICIAN CONTACTED THE ELECTROSURGICAL GENERATOR MANUFACTURER BECAUSE THE PATIENT DID HEMORRHAGE AND NEEDED 4 CLIPS TO STOP THE HEMORRHAGE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT REQUIRED HEMOSTASIS WITH FOUR CLIPS. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: Gastrointestinal Hemorrhage

  MAUDE report 14487571 ↗
• MalfunctionOct 8, 2021Failure to Conduct; Nonstandard Device; Material Separation; Failure to Conduct; Nonstandard Device; Material Separation

  IN PREPARATION FOR A POLYPECTOMY, THE USER SELECTED A COOK ACUSNARE POLYPECTOMY SNARE. THE USER OPENED THE PACKAGE AND CHECKED THE FUNCTION OF DEVICE, AND FOUND OUT THE THERE IS NO ELECTRICITY CONTACT ON DEVICE. NO USE ON PATIENT. THIS WAS OBSERVED PRIOR TO USE, THERE IS NO IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12598719 ↗
• MalfunctionSep 29, 2021Nonstandard Device; Product Quality Problem; Material Separation; Nonstandard Device; Product Quality Problem; Material Separation

  IN PREPARATION FOR AN ENDOSCOPIC MUCOSAL RESECTION (EMR) IN THE STOMACH , THE PHYSICIAN SELECTED A COOK ACUSNARE POLYPECTOMY SNARE. INITIALLY IT WAS REPORTED THAT THE PHYSICIAN OPENED THE PACKAGE, CHECKED THE DEVICE AND FOUND THAT THE HANDLE COULDN'T CONTROL THE SNARE. THERE WAS NO REPORTABLE INFORMATION AT THIS TIME. OUR EVALUATION OF THE RETURNED DEVICE ON 09/01/2021 DETERMINED THAT THE HANDLE WAS BROKEN. THE SNARE WAS RETURNED EXTENDED AND COULD NOT BE RETRACTED [SUBJECT OF REPORT]. THIS OCCURRED PRIOR TO PATIENT CONTACT; THERE WAS NO IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12550062 ↗
• MalfunctionJun 22, 2021Failure to Conduct; Failure to Conduct

  DURING A POLYPECTOMY, THE PHYSICIAN USED AN ACUSNARE POLYPECTOMY SNARE. IT WAS REPORTED THAT THE USER OPENED THE PACKAGE AND ADVANCED THE DEVICE TO DESIRED POSITION AND PLUGGED THE DEVICE WITH POWER, BUT FOUND WHEN ELECTROSURGICAL GENERATOR IS ACTIVATED, NO ELECTROSURGICAL CURRENT WAS PRESENT AT THE SNARE HEAD AND CANNOT REMOVE THE POLYPS. THE USER THEN CHANGED TO ANOTHER 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 12041424 ↗
• MalfunctionMar 25, 2021Failure to Conduct; Failure to Conduct

  DURING AN ENDOSCOPIC MUCOSAL RESECTION PROCEDURE THE PHYSICIAN USED AN ACUSNARE POLYPECTOMY SNARE. THE DEVICE WAS NOT CONDUCTING ELECTRICITY. THE PHYSICIAN THEN CHANGED TO ANOTHER MANUFACTURES DEVICE TO COMPLETE THE PROCEDURE. HOT BIOPSY FORCEPS WERE USED TO CLEAN THE WOUND AND THE WOUND WAS CLOSED WITH A HARMONY CLAMP. 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 11567424 ↗
• MalfunctionJan 28, 2021Material Separation; Material Separation

  DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD), THE PHYSICIAN USED A COOK ACUSNARE POLYPECTOMY SNARE. THE USER ADVANCED THE DEVICE TO THE DESIRED POSITION AND PUSHED THE SNARE OUT OF THE SHEATH TO CAPTURE THE POLYP AND FOUND OUT THAT THE SHEATH NEAR THE HANDLE WAS BROKEN. THE USER CHANGED TO ANOTHER ONE OF THE SAME DEVICE TO COMPLETE THE PROCEDURE. PER FURTHER INFORMATION RECEIVED THE USER DID NOT HAVE DIFFICULTY RETRACTING THE SNARE. OUR EVALUATION OF THE RETURNED DEVICE ON 07-JAN-2021 DETERMINED THAT THE SNARE WAS ADVANCED AND COULD NOT BE RETRACTED DUE TO THE CATHETER BEING DETACHED FROM THE HANDLE (SUBJECT OF THIS 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 Consequences Or Impact To Patient

  MAUDE report 11246090 ↗
• MalfunctionNov 24, 2020Failure to Conduct; Failure to Conduct

  DURING AN ENDOSCOPIC POLYPECTOMIE IN THE COLON, THE PHYSICIAN USED A COOK ACUSNARE POLYPECTOMY SNARE. COAGULATION DID NOT WORK, EVERYTHING WAS PROPERLY CONNECTED. THE FOLLOWING ADDITIONAL INFORMATION WAS PROVIDED ON 03-NOV-2020: DURING A COLONOSCOPY, USE OF A SNARE TO RESECT A POLYP. INTRODUCTION OF THE SNARE INTO THE OPERATING CHANNEL, OPENING OF THE SNARE, BUT NO COAGULATION. THE CORD PROPERLY CONNECTED TO THE ERBE GENERATOR. NO ERROR MESSAGE ON THE GENERATOR. IT WAS UNPLUGGED AND PLUGGED IN [AGAIN], BUT STILL NO CLOTTING. USE OF ANOTHER SNARE. NO PROBLEM WITH THE SECOND. 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 10897015 ↗
• MalfunctionMar 17, 2020Failure to Cut; Failure to Cut

  DURING AN ENDOSCOPIC PROCEDURE, THE PHYSICIAN USED A COOK ACUSNARE POLYPECTOMY SNARE. THE OUTER SHEATH BUCKLED NOT ALLOWING THEM TO CLOSE THE END SNUGLY, IT REQUIRED INCREASED HEAT BUT NOT ADEQUATE RESULT [DEVICE DOES NOT REMOVE POLYP AS INTENDED]. CLARIFICATION WAS RECEIVED ON 05-MAR-2020 INDICATING THAT THE CLIPS WERE PLACED AS A PREVENTATIVE MEASURE AND NOT INTERVENTION TO PRECLUDE A SERIOUS INJURY. 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. CLIPS WERE PLACED AS A PREVENTATIVE MEASURE. 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 9843711 ↗
• InjuryMar 9, 2020Failure to Cut; Failure to Cut

  DURING A COLONOSCOPY PROCEDURE, THE PHYSICIAN USED TWO COOK ACUSNARE POLYPECTOMY SNARES. THE SNARE WAS NOT CUTTING THROUGH THE POLYP. THE REMNANT WAS THEN CLIPPED TO FINISH THE PROCEDURE. ONE (1) UNUSED DEVICE WAS ALSO AFFECTED PER THE USER. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT REQUIRED CLIPPING OF THE REMNANT DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: Tissue Damage

  MAUDE report 9808585 ↗
• MalfunctionFeb 21, 2020Failure to Cut; Failure to Cut

  DURING AN COLONOSCOPY PROCEDURE, THE PHYSICIAN USED A COOK ACUSNARE POLYPECTOMY SNARE. THE SNARE DID NOT RELEASE [SNARE WILL NOT CUT THROUGH ENTIRE POLYP]. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT REQUIRED CLIPPING OF THE REMNANT. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: Hemostasis

  MAUDE report 9741568 ↗