Single Use Loop Cutter FS-410 FS-410URecalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 04953170401053), received between Oct 20, 2021 and May 21, 2025 — classified as 6 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Entrapment of Device” (4 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 18, 2026.

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryMay 21, 2025Break; Entrapment of Device; Difficult to Open or Close; Break; Entrapment of Device; Difficult to Open or Close

  IT WAS REPORTED THAT DURING A THERAPEUTIC COLONOSCOPY AND POLYP REMOVAL, THE ENDOLOOP PLACEMENT WAS NOT WHAT THE PHYSICIAN QUITE WANTED SO THE DECISION WAS MADE TO USE THE LOOP CUTTER TO CUT AND TRY AGAIN. DURING THE ATTEMPT TO CUT THE ENDOLOOP WITH A LOOP CUTTER, THE CUTTER INTERNALLY (INSIDE SHEATH) MUST HAVE PULLED AND SNAPPED AS THE LOOP CUTTER WOULD NOT OPEN OR CLOSE, WAS STUCK ON TISSUE, AND THE HANDLE WAS NOT OPENING OR CLOSING THE CUTTER. A WIRE CUTTER WAS USED TO CUT THE SHEATH FROM OUTSIDE THE HANDLE AND PULL OFF THE SCOPE (DO EXCHANGE AND LEAVE THE SHEATH HANGING OUTSIDE THE PATIENT, GO BACK IN, AND INTRODUCE SURGICAL SCISSORS TO PUT THE TISSUE TO RELEASE THE STUCK LOOP CUTTER OFF OF THE PATIENT). THE PROCEDURE WAS COMPLETED WITHOUT ANY REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22064352 ↗
• InjuryOct 14, 2024Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT THE SUBJECT DEVICE WAS USED BY THE CUSTOMER TO REMOVE THE SUTURES OF THE J-TUBE INSTEAD OF ENDO SCISSORS. THE SUTURE THEN GOT STUCK IN THE LOOP AND THE CUSTOMER HAD TO GO IN WITH A SECOND SCOPE AND ACTUAL ENDO SCISSORS TO FREE THE OTHER SCOPE AND LOOP. THE SURGERY WAS PROLONGED FOR ABOUT AN HOUR. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20445692 ↗
• InjuryOct 7, 2024Entrapment of Device; Physical Resistance/Sticking; Entrapment of Device; Physical Resistance/Sticking

  IT WAS REPORTED THAT THE ISSUE OCCURRED DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) WITH J-TUBE REMOVAL PROCEDURE (J-TUBE WAS PREVIOUSLY SUTURED TO THE SMALL BOWEL WALL TO REDUCE MIGRATION).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20386205 ↗
• InjuryOct 2, 2023Entrapment of Device; Entrapment of Device

  THE CUSTOMER REPORTED DURING A THERAPEUTIC GASTROSCOPY PROCEDURE FOR A FEMALE, TWENTY-THREE YEAR OLD PATIENT THEY TRIED TO CUT THE SUTURE FROM THE PROBE WITH SINGLE USE LOOP CUTTER FS-410. THE LOOP CUTTER DID NOT CUT THE SUTURE SO THE CUSTOMER TRIED TO CUT IT WITH FS-5U-1 LOOP CUTTER. THE REUSABLE VERSION MODEL, FS-5U-1, BECAME STUCK WHILE CUTTING AND THE CUSTOMER WAS UNABLE TO RELEASE THE JAWS OF THE LOOP CUTTER. THEY CUT THE HANDLE AND RETRIEVED THE SCOPE FROM THE PATIENT. THE PATIENT WAS TRANSFERRED TO ANOTHER HOSPITAL WITH THE LOOP CUTTER STILL HANGING OUT OF THE PATIENTS MOUTH. A SECOND ENDOSCOPIC EXAMINATION WAS PERFORMED AND WITH LIGHT PULLING FORCE THE CLIP WITH THE SUTURE THREAD WAS ABLE TO BE REMOVED. THE CUSTOMER LATER CONFIRMED THERE WAS NO ADDITIONAL HARM TO THE PATIENT AND THE CURRENT STATUS OF THE PATIENT IS GOOD. A FEEDING PROBE WAS PLACED TO ENSURE THE PATIENT RECEIVES SUFFICIENT INTAKE. THE JEJUNAL EXTENSION WAS CLIPPED TO THE MUCOSA WITH A SUTURE AND THE SUTURE BECAME STUCK IN THE FS-5U-1 LOOP CUTTER. THE LOOP CUTTER WITH SUTURE AND EXTENSION HAVE BEEN REMOVED. THIS EVENT IS REPORTED UNDER THE FOLLOWING RELATED PATIENT IDENTIFIERS: (B)(6) REPRESENTS SINGLE USE LO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17856605 ↗
• InjuryJul 27, 2023Difficult to Remove; Difficult to Remove

  THE CUSTOMER REPORTED TO OLYMPUS THAT DURING SUTURING AFTER ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD), THE TOOTH CAUGHT THE THREAD AND IT COULD NOT BE REMOVED. THE THREAD WAS CUT BY INSERTING GRASPING FORCEPS FROM THE OPPOSITE SIDE AND REMOVING THE THREAD. THE PROCEDURE WAS COMPLETED WITH NO REPORTS OF PATIENT OR USER HARM ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17410075 ↗
• MalfunctionOct 24, 2022Mechanical Problem; Mechanical Problem

  IT WAS REPORTED WHEN THE SUTURE THREAD WAS CUT, THE THREAD COULD NOT BE CUT ONCE THE FORCEPS WERE CLOSED BY PINCHING THE THREAD , AND THE FORCEPS COULD NOT BE OPENED EVEN IF THE SLIDER WAS MOVED WHILE THE THREAD WAS BEING BITTEN AS DESCRIBED BY THE REPORTER. THE USER PULLED THE FORCEPS AND THE THREAD WAS CUT AND THE PROCEDURE WAS COMPLETED. ACCORDING TO THE REPORTER, AFTER SUTURING THE FIRST LESION, THE THREAD WAS CUT WITHOUT ANY PROBLEMS. ACCORDING TO THE REPORTER, THE ISSUE OCCURRED WHEN THE THREAD WAS CUT FOR THE SECOND LESION. THE INTENDED ENDOSCOPIC HAND-SUTURING (EHS) THERAPEUTIC PROCEDURE WAS COMPLETED USING THE SAME SET OF EQUIPMENT WITH NO PATIENT HARM OR IMPACT REPORTED. NO USER INJURY WAS REPORTED. THE DEVICE WAS USED WITH VLOCK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15656829 ↗
• MalfunctionSep 1, 2022Break; Break

  THE CUSTOMER REPORTED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE, THE LOOP CUTTER BROKE WHILE IN THE PATIENT. THE DEVICE WOULD NOT OPEN OR CLOSE AND WAS STUCK TO THE SUTURE THAT NEEDED TO BE CUT. THE CUSTOMER REPORTED THE PROCEDURE WAS COMPLETED. ADDITIONAL DETAILS WERE REQUESTED REGARDING THE REPORTED EVENT; HOWEVER, NO FURTHER INFORMATION WAS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15338189 ↗
• MalfunctionAug 31, 2022Failure to Cut; Failure to Cut

  THE CUSTOMER REPORTED THAT AFTER A RECTAL ENDOSCOPIC HAND SUTURING (EHS) PROCEDURE, WHEN THE SUBJECT DEVICE WAS USED TO CUT THE SUTURE (NEEDLE THREAD) FOR THE FIRST TIME, THE THREAD GOT ENTANGLED IN THE LOOP CUTTER AND COULD NOT BE CUT. THE LOOP CUTTER COULD NOT BE REMOVED FROM THE ENDOSCOPE. SINCE IT WAS A RECTAL CASE, IT WAS REMOVED WHILE PASSING THROUGH AN ENDOSCOPE OUTSIDE THE BODY, AND THE THREAD WAS REMOVED OUTSIDE THE BODY. THE PROCEDURE WAS COMPLETED USING ANOTHER FS-410U. NO HEALTH HAZARDS OCCURRED. ADDITIONAL INFORMATION WAS LATER RECEIVED REGARDING THE REPORTED EVENT. THE FS-410U WAS REMOVED TOGETHER WITH THE ENDOSCOPE. THE THREAD (SUTURE) HAS A LENGTH THAT EXTENDS OUTSIDE OF THE BODY, AND THE THREAD IS EXCISED OUTSIDE THE BODY. THE MODEL NUMBER OF THE ENDOSCOPE WAS NOT KNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15329147 ↗
• InjuryOct 20, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT IS REPORTED BY THE CUSTOMER, DURING A THERAPEUTIC COLONOSCOPY USING A SINGLE USE LOOP CUTTER, THE DEVICE MALFUNCTIONED INSIDE THE PATIENT. THE BROKEN PARTS WERE RETRIEVED FROM THE PATIENT. THE DEVICE MALFUNCTION CAUSED A CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL CONSEQUENCES TO THE PATIENT HAVE BEEN REPORTED. ADDITIONAL DETAILS REGARDING THE PATIENT AND PROCEDURE HAVE BEEN REPORTED. AT THIS TIME, NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 12665816 ↗