SINGLE USE LOOP CUTTER FS-410
Received May 29, 2026 · Event occurred May 8, 2026
Report 9614641-2026-00561 · MDR key 25337802
Device
Product problems
- Difficult to Remove
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE INVESTIGATION IS ONGOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETED OR IF ADDITIONAL INFORMATION BECOMES AVAILABLE.
Description of Event or Problem
IT WAS REPORTED THAT DURING A POLYPECTOMY, THE CLINICIAN FIRST TRIED TO CUT THE POLYP USING A COLD SNARE (UNKNOWN MANUFACTURER), BUT FAILED. NEXT, THE CLINICIAN TRIED TO CUT IT WITH THE DISPOSABLE ELECTROSURGICAL SNARE, BUT FAILED. AFTER THAT, WHILE ATTEMPTING TO CUT THE POLYP WITH THE SINGLE-USE LOOP CUTTER, THE SCISSORS BIT INTO THE MUCOSA, MAKING IT IMPOSSIBLE TO REMOVE THE POLYP. THE CLINICIAN CUT THE HANDLE SECTION AND REMOVED THE ENDOSCOPE. THE CLINICIAN THEN ATTEMPTED A POLYPECTOMY USING THE SAME DISPOSABLE ELECTROSURGICAL SNARE THAT HAD FAILED PREVIOUSLY, AND THIS TIME IT WAS SUCCESSFUL. SINCE THE CLINICIAN WAS ABLE TO REMOVE THE SINGLE-USE LOOP CUTTER AT THE SAME TIME, IT WAS RETRIEVED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING THE DISPOSABLE ELECTROSURGICAL SNARE. THE PROCEDURE WAS DELAYED BY ABOUT 30 MINUTES. THERE WERE NO REPORTS OF PATIENT HARM.