MalfunctionFGX
STERIS EXACTO COLD SNARE
Received May 23, 2022 · Event occurred May 9, 2022
Report MW5109849 · MDR key 14488298
Device
Generic name
Snare, Non-electrical
Manufacturer
Steris /isomedix Operations Inc.Catalog number
00711115
Lot number
2202752
Product problems
- Break
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
STERIS EXACTO SNARE THAT WAS BEING USED TO REMOVE COLON POLYP BROKE AT THE HANDLE AS IT WAS CUTTING THE POLYP AND SNARE QUIT WORKING. NO HARM TO PATIENT OR TEAM MEMBERS, BUT PATIENT HAD TO BE TRANSFERRED TO ANOTHER FACILITY TO COMPLETE PROCEDURE. FDA SAFETY REPORT ID# (B)(4).