MAUDE Adverse Event Report: STERIS / ISOMEDIX OPERATIONS INC. STERIS LARIAT; SNARE, FLEXIBLE

Lot Number 2201659

Device Problems Material Discolored (1170); Physical Resistance/Sticking (4012)

Patient Problem Insufficient Information (4580)

Event Date 07/28/2022

Event Type  malfunction  

Event Description

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).

• Brand Name: STERIS LARIAT
• Type of Device: SNARE, FLEXIBLE
• Manufacturer (Section D): STERIS / ISOMEDIX OPERATIONS INC.
• MDR Report Key: 15156136
• MDR Text Key: 297241190
• Report Number: MW5111242
• Device Sequence Number: 1
• Product Code: FDI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 08/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/02/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: 2201659
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other