inforMED
InjuryPTS

SINGLE USE LOOP CUTTER FS-410

Received Oct 14, 2024 · Event occurred Sep 27, 2024

Report 2429304-2024-0000437 · MDR key 20445692

Device

Generic name

Loop Cutter

Model number

FS-410U

Lot number

2XK

Product problems

  • Entrapment of Device
  • Entrapment of Device

Patient

NA · Unknown

  • No Clinical Signs, Symptoms or Conditions
  • No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

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.