LOOP CUTTER FS-5U-1Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 04953170033445), received between Feb 28, 2019 and Sep 23, 2024 — classified as 6 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Difficult to Remove” (6 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• InjurySep 23, 2024Difficult to Remove; Difficult to Remove

  IT WAS REPORTED DURING AN UNSPECIFIED THERAPEUTIC PROCEDURE WHILE CUTTING THE LOOP OF THE SINGLE USE LIGATING DEVICE WITH THE LOOP CUTTER, THE LOOP GOT CAUGHT IN THE CUTTER BLADE AND COULD NOT BE REMOVED. THE USER ATTEMPTED TO OPERATE THE HANDLE PART WHILE KEEPING THE ENDOSCOPE AS STRAIGHT AS POSSIBLE BUT THERE WAS NO IMPROVEMENT. A SPARE LOOP CUTTER WAS USED TO CUT THE DEVICES AND REMOVE THEM FROM THE PATIENT. THE PROCEDURE WAS THEN COMPLETED. THERE WAS NO REPORTED PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20285588 ↗
• InjuryJun 27, 2024Difficult to Remove; Difficult to Remove

  IT WAS REPORTED DURING A THERAPEUTIC POLYP REMOVAL WHEN TRYING TO CUT THE EXCESS THREAD OF THE SINGLE USE LIGATING DEVICE WITH A LOOP CUTTER, A PROBLEM OCCURRED IN WHICH THE THREAD GOT CAUGHT IN THE LOOP CUTTER GROOVE AND THE LOOP CUTTER COULD NOT BE REMOVED FROM THE PATIENT. THE SCOPE WAS SLOWLY REMOVED, AND THEN ANOTHER LOOP CUTTER WAS INSERTED AND REMOVED TOGETHER WITH THE SCOPE TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19623782 ↗
• 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 17856549 ↗
• MalfunctionJul 10, 2023Difficult to Remove; Difficult to Remove

  THE CUSTOMER REPORTED TO OLYMPUS THAT THE SCISSORS WERE CAUGHT IN THE LOOP CUTTER AND COULD NOT BE REMOVED. IT BECAME IMPOSSIBLE TO DO ANYTHING BY DIGGING BETWEEN TEETH WHEN REMOVING POLYPS. CORRESPOND BY CUTTING THE HAND PART WITH NIPPERS. THE EVENT OCCURRED DURING A DIAGNOSTIC ENDOSCOPY PROCEDURE. THERE WAS NO DELAY, AND THE PROCEDURE WAS COMPLETED WITH A SIMILAR DEVICE. THERE WAS NO PATIENT HARM ASSOCIATED WITH THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17295398 ↗
• MalfunctionMar 16, 2023Mechanical Problem; Failure to Cut; Mechanical Problem; Failure to Cut

  IT WAS REPORTED THE DOCTOR TRIED TO CUT THE INDWELLING SNARE; HOWEVER, IT COULD NOT BE CUT AND COULD NOT BE OPENED OR CLOSED. IT WERE STUCK IN THE BODY, USER WAS ABLE TO REMOVE IT BY FOLLOWING THE INSTRUCTIONS IN THE INSTRUCTION MANUAL. THE ISSUE OCCURRED DURING A THERAPEUTIC UNSPECIFIED PROCEDURE. THE INTENDED PROCEDURE WAS COMPLETED WITH NO HARM OR INJURY TO THE PATIENT. NO HARM REPORTED, NO USER INJURY REPORTED DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16551037 ↗
• MalfunctionSep 12, 2022Difficult to Remove; Difficult to Remove

  THE CUSTOMER REPORTED TO OLYMPUS, DURING A DIAGNOSTIC ESOPHAGOGASTRODUODENOSCOPY, THE LOOP CUTTER BECAME STUCK AFTER CUTTING THROUGH A SUTURE. THE PROCEDURE WAS COMPLETED USING AN UNKNOWN DEVICE TO REMOVE THE LOOP CUTTER. THE CUSTOMER REPORTED THE DEVICE WAS INSPECTED PRIOR TO THE PROCEDURE WITH NO ANOMALIES FOUND. THERE WAS NO HARM OR INJURY TO THE PATIENT ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15404909 ↗
• MalfunctionJun 15, 2021Device Reprocessing Problem; Device Reprocessing Problem

  IT WAS REPORTED TO OLYMPUS THAT THE LOOP CUTTER WAS NOT REPROCESSED AND WAS USED ON A PATIENT. NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11997759 ↗
• MalfunctionFeb 13, 2020Entrapment of Device; Failure to Cut; Physical Resistance/Sticking; Entrapment of Device; Failure to Cut; Physical Resistance/Sticking

  A REPORT WAS RECEIVED AT THE SERVICE CENTER FOR A LOOP CUTTER (FS-5U-1), LOT NUMBER 96 K, THAT ¿STOPPED WORKING, NOT CUTTING AND GOT STUCK¿ DURING A PROCEDURE. THE LOOP CUTTER WAS NOT INSPECTED PRIOR TO THE PROCEDURE AND WAS NOT REPROCESSED AS IT WAS THE INITIAL USE OF THE DEVICE. THE PHYSICIAN WAS PERFORMING A THERAPEUTIC RETRIEVAL OF A BARIATRIC RING WHEN THE LOOP CUTTER WOULD NOT CUT, REMAINED CLOSED AND GOT STUCK NEAR THE BARIATRIC RING. THE REPORTED INCIDENT OCCURRED AT THE BEGINNING OF THE PROCEDURE AND THE DEVICE WAS REMOVED FROM THE PATIENT. IT WAS REPORTED THE PATIENT WAS UNDER GENERAL ANESTHESIA AND THE PROCEDURE WAS PROLONGED PAST 90 MINUTES. IN ADDITION, IT WAS REPORTED THERE WAS NO ADDITIONAL MEDICAL INTERVENTION, PROLONGED POST-OP OBSERVATION OR HOSPITALIZATION PROVIDED TO THE PATIENT. THE LOOP CUTTER DID NOT FALL APART AND NO ITEMS FELL INTO THE PATIENT. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. A GASTROSCOPE FROM FUJINOM WAS ALSO USED IN THE PROCEDURE. IT WAS REPORTED THERE WAS NO PATIENT INJURY AND THE PATIENT WAS FINE WITH NO PROBLEMS IN THE POST PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9706324 ↗
• InjurySep 5, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE SERVICE CENTER RECEIVED A MEDWATCH REPORT WHICH STATES, " ADMITTED FOR ESOPHAGEAL STENT PLACEMENT. STENT PLACED (B)(6) 2019 IN ENDO, PATIENT TAKEN BACK THE FOLLOWING DAY FOR STENT REPOSITIONING SINCE STENT HAD MIGRATED OUT OF PLACE. MM DOCUMENTS IN PROCEDURE NOTE THERE WERE MULTIPLE EQUIPMENT MALFUNCTIONS CAUSING THE PROCEDURE TO TAKE LONGER THAN NORMAL. MD WAS CONCERNED FOR AIRWAY EDEMA, DECISION WAS MADE TO LEAVE PATIENT INTUBATED AND TRANSFER TO MICU. PATIENT WAS EXTUBATED (B)(6) WITH NO COMPLICATIONS AND LATER TRANSFERRED TO THE 7TH FLOOR. THIS IS A DISPOSABLE VALVE USED TO ACTIVATE SUCTION THROUGH THE ENDOSCOPE. MALFUNCTION EVENT: VALVE BECAME STUCK AND BROKEN WHEN TECH ATTEMPTED TO REMOVE FROM SCOPE DURING THE PROCEDURE. A NEW ENDOSCOPE HAD TO BE BROUGHT IN TO CONTINUE WITH CASE. THIS IS A REUSABLE DEVICE BUT IT WAS BRAND NEW WHEN TECH OPENED FOR USE.¿

  Patient problems: Injury

  MAUDE report 8966189 ↗
• InjurySep 5, 2019Break; Migration or Expulsion of Device; Physical Resistance/Sticking

  THE SERVICE CENTER RECEIVED A MEDWATCH MW5088292 REPORT WHICH STATES, " ADMITTED FOR ESOPHAGEAL STENT PLACEMENT. STENT PLACED (B)(6) 2019 IN ENDO, PATIENT TAKEN BACK THE FOLLOWING DAY FOR STENT REPOSITIONING SINCE STENT HAD MIGRATED OUT OF PLACE. MD DOCUMENTS IN PROCEDURE NOTE THERE WERE MULTIPLE EQUIPMENT MALFUNCTIONS CAUSING THE PROCEDURE TO TAKE LONGER THAN NORMAL. MD WAS CONCERNED FOR AIRWAY EDEMA, DECISION WAS MADE TO LEAVE PATIENT INTUBATED AND TRANSFER TO MICU. PATIENT WAS EXTUBATED (B)(6) WITH NO COMPLICATIONS AND LATER TRANSFERRED TO THE 7TH FLOOR. THIS IS A DISPOSABLE VALVE USED TO ACTIVATE SUCTION THROUGH THE ENDOSCOPE. MALFUNCTION EVENT: VALVE BECAME STUCK AND BROKEN WHEN TECH ATTEMPTED TO REMOVE FROM SCOPE DURING THE PROCEDURE. A NEW ENDOSCOPE HAD TO BE BROUGHT IN TO CONTINUE WITH CASE. THIS IS A REUSABLE DEVICE BUT IT WAS BRAND NEW WHEN TECH OPENED FOR USE.¿

  Patient problems: Edema

  MAUDE report 8966156 ↗
• InjuryMay 14, 2019Entrapment of Device; Entrapment of Device

  THE MANUFACTURER WAS INFORMED THAT DURING A THERAPEUTIC TOTAL COLONOSCOPY PROCEDURE, THE POLYLOOP AND LOOP CUTTER BECAME STUCK IN THE PATIENT CAUSING A RECTUM LACERATION. THE DOCTOR ATTEMPTED TO USE THE LOOP CUTTER TO CUT THE LOOP; HOWEVER, IT BECAME ENTANGLE WITH THE PATIENT¿S MUCOUS MEMBRANE. THE INTENDED PROCEDURE WAS COMPLETED. THIS IS 1 OF 2 COMPLAINTS.

  Patient problems: Laceration(s)

  MAUDE report 8608330 ↗
• MalfunctionApr 17, 2019Difficult to Remove; Difficult to Remove

  DURING AN UNSPECIFIED PROCEDURE, THE SUBJECT DEVICE WAS USED. THE USER TRIED TO CUT THE RESIDUAL END OF THE LOOP USED FOR LIGATING TISSUE WITH THE DEVICE. THE USER COULD NOT OPEN THE DEVICE. THE USER COULD NOT REMOVE THE DEVICE FROM THE PATIENT. AFTER THAT, THE USER CUT THE DEVICE. THE USER RETRIEVED THE DEVICE WITH AN UNSPECIFIED WAY. NO PATIENT INJURY WAS REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8522078 ↗
• MalfunctionFeb 28, 2019Difficult to Remove; Difficult to Remove

  OLYMPUS WAS INFORMED THAT DURING AN UNSPECIFIED PROCEDURE, THE SURGEON WAS USING THE LOOP CUTTER TO REMOVE A BRONCHIAL STENT BY ITS¿ LASSO, WHEN IT BECAME STUCK. THE USER CUT THE INSERTION PART OF THE DEVICE. THE USER REMOVED THE ENDOSCOPE FROM THE PATIENT WHILE LEAVING THE DEVICE INSIDE THE PATIENT. THE USER INSERTED A 4MM ENDOSCOPE AND USED AN ENDOSCOPIC CAMERA, WITH A LAPAROSCOPIC SCISSOR TO CUT THE STRING AND REMOVED THE REMAINING PORTION OF THE LOOP CUTTER DEVICE FROM THE PATIENT. THE INTENDED PROCEDURE TO REMOVE THE STENT WAS THEN COMPLETED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8380648 ↗