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

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 04953170033407), received between Oct 13, 2022 and Nov 21, 2023 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Difficult to Remove” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryNov 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS REVIEWED THE FOLLOWING LITERATURE TITLED "ENDOSCOPIC INTERNALIZATION BY CUTTING VERSUS REMOVAL OF THE ENDOSCOPIC TRANSPAPILLARY NASO-GALLBLADDER DRAINAGE TUBE IN PREOPERATIVE MANAGEMENT OF ACUTE CHOLECYSTITIS: A RETROSPECTIVE MULTICENTER COHORT STUDY." ABSTRACT BACKGROUND: ENDOSCOPIC TRANSPAPILLARY NASO-GALLBLADDER DRAINAGE (ENGBD)HAS BEEN REPORTED TO BE AN EFFECTIVE TREATMENT OPTION FOR ACUTE CHOLECYSTITIS. AT OUR INSTITUTION, ENGBD WAS FIRST PLACED FOR EXTERNAL FISTULA MANAGEMENT, AND ENDOSCOPIC INTERNALIZATION BY CUTTING WAS PERFORMED, SHIFTING TO ENDOSCOPIC TRANSPAPILLARY GALLBLADDER STENTING (EGBS) AFTER IMPROVEMENT OF CHOLECYSTITIS. HOWEVER, THERE HAS BEEN NO COMPARATIVE STUDY TO DEFINE WHICH PREOPERATIVE MANAGEMENT IS BETTER: CONVERTING ENGBD TO EGBS OR REMOVING ENGBD. THE STUDY AIMED TO COMPARE THE INCIDENCE RATE OF THE LATE ADVERSE EVENTS (AES) RELATED TO BILIARY SYSTEM BETWEEN SHIFTING FROM ENGBD TO EGBS AND REMOVAL OF ENGBD. METHODS: WE RETROSPECTIVELY STUDIED 122 PATIENTS WHO UNDERWENT ENGBD FOR ACUTE CHOLECYSTITIS BETWEEN JANUARY 2010 AND OCTOBER 2022. THE PATIENTS WERE DIVIDED INTO TWO GROUPS: THE CUTTING GROUP (CONVERTING ENGBD TO EGBS) AND THE REMOVAL GROUP

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Pancreatitis; Unspecified Hepatic or Biliary Problem

  MAUDE report 18185507 ↗
• MalfunctionJan 13, 2023Difficult to Remove; Difficult to Remove

  AN OLYMPUS EMPLOYEE REPORTED ON BEHALF OF A CUSTOMER, THE LOOP CUTTER WHEN USED TO CUT THE THREAD AFTER TISSUE SUTURING, THE THREAD GOT CAUGHT IN THE JAW OF THE SCISSORS AT TIP AND JAW OF SCISSORS WERE CUT. THE JAWS OF SCISSORS COULD NO LONGER BE OPENED OR CLOSED AND AS A RESULT, THE LOOP CUTTER GOT STUCK IN THE PATIENT¿S BODY. THE SCOPE BECAME DIFFICULT TO REMOVE AND ANOTHER SCOPE AND TREATMENT TOOL WERE USED TO RELEASE THE STACK. THE PROCEDURE WAS COMPLETED USING THE SUBJECT DEVICE. THE EVENT OCCURRED DURING A THERAPEUTIC DUODENAL ENDOSCOPIC MUCOSAL RESECTION (EMR). THERE WAS NO REPORT OF PATIENT HARM ASSOCIATED WITH THIS PROCEDURE. THE SUBJECT DEVICE WAS DISPOSED OF AND COULD NOT BE COLLECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16156035 ↗
• MalfunctionNov 21, 2022Failure to Cut; Failure to Cut

  THE CUSTOMER REPORTED TO OLYMPUS DURING A DIAGNOSTIC EGD PROCEDURE FOR EPIGASTRIC ABDOMINAL PAIN WITH SUSPECTED GERD STATUS POST ROUX-EN-Y, THE SUBJECT DEVICE FAILED. THE SUBJECT DEVICE WAS UNABLE TO CUT THROUGH THE SUTURE IN THE PATIENT AND COULD NOT BE EXTRACTED. THE CUSTOMER REPORTED THE DOCTOR WAS ABLE TO EXTRACT THE SCOPE BEING USED AND WILL USE ANOTHER SCOPE TO CONTINUE THE PROCEDURE. CUSTOMER REPORTED THAT THE PROCEDURE WAS COMPLETED AND THEY WERE ABLE TO UTILIZE A NEEDLE KNIFE TO CUT THE STITCH THAT THE DEVICE WAS CLAMPED ON. THERE WERE NO PROCEDURAL OR ANATOMICAL CHALLENGES THAT COULD HAVE CONTRIBUTED TO THE REPORTED ISSUE. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. THE PATIENT'S CURRENT CONDITION IS REPORTED AS STABLE, AT BASELINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15834674 ↗
• MalfunctionOct 13, 2022Entrapment of Device; Entrapment of Device

  THE USER FACILITY REPORTED THAT DURING A POLYPECTOMY OF THE LARGE INTESTINE PROCEDURE, WHEN ATTEMPTING TO CUT THE REMAINING LOOP OF THE SNARE WITH THE SUBJECT DEVICE, THE LOOP WAS CAUGHT IN THE CUTTER (JAWS) AND COULD NOT BE REMOVED. ANOTHER LOOP CUTTER WAS INSERTED THROUGH THE SIDE OF THE ENDOSCOPE AND CUT THE LOOP. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO HEALTH HAZARD TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15599440 ↗