MalfunctionFDI
STERIS LARIAT
Received Aug 2, 2022 · Event occurred Jul 28, 2022
Report MW5111242 · MDR key 15156136
Device
Product problems
- Material Discolored
- Physical Resistance/Sticking
Patient
Unknown
- Insufficient Information
- Insufficient Information
Narrative
Description of Event or Problem
MD TRYING TO REMOVE LARGE GASTRIC POLYP WITH SNARE CAUTERY AND CAUTERY DID NOT WORK WITH THE SNARE. SNARE IS STERIS LARIAT LOT #2201659. IT IS NOT EXPIRED BUT WE HAVE NOTICED THE HANDLE LOOKS YELLOWED. THE SNARE GOT STUCK ON THE POLYP AND WE HAD TO CUT IT REMOVING THE HANDLE TO GET THE SCOPE OUT OF THE PATIENT. WE USED ANOTHER SNARE TO REMOVE THE FIRST SNARE AND DID NOT REMOVE THE POLYP. FDA SAFETY REPORT ID# (B)(4).