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

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04953170401039), received between Apr 21, 2023 and May 2, 2023 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Difficult to Open or Close” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 2, 2023Difficult to Open or Close; Difficult to Open or Close

  AN OLYMPUS REPRESENTATIVE REPORTED TO OLYMPUS ON BEHALF OF THE CUSTOMER, THAT A PATIENT EXHIBITED BLEEDING AND HEMATOMA, DURING SUTURING AFTER AN ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD). BULGING OF THE SURROUNDING MUCOSA WAS OBSERVED, SO TWO V-LOC SUTURES WERE USED. THE PHYSICIAN TRIED TO CUT THE EXCESS THREAD OF THE V-LOC WITH THE SINGLE USE LOOP CUTTER FS-410, BUT IT INITIALLY DID NOT OPEN. THE PHYSICIAN WAS EVENTUALLY ABLE TO OPEN IT. AND HE WAS ABLE TO CUT THE THREAD AND COLLECT THE LOOP CUTTER. THERE WAS NO HARM OR USER INJURY REPORTED DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16857772 ↗
• MalfunctionApr 21, 2023Failure to Cut; Failure to Cut

  THE CUSTOMER REPORTED TO OLYMPUS THAT, AFTER SUTURING IN A STOMACH CASE (EHS: ENDOSCOPIC HAND-SEWN SUTURING METHOD), WHEN TRYING TO CUT THE THREAD USING THE SINGLE USE LOOP CUTTER FS-410, THE THREAD CAUGHT, AND THE SLIDER STOPPED MOVING. THE CUSTOMER SWITCHED TO A HOOK KNIFE TO CUT THE THREAD AND THE ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD) PROCEDURE WAS COMPLETED. THERE WAS NO REPORT OF PATIENT OR USER HARM ASSOCIATED WITH THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16791803 ↗