MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SINGLE USE POLYPECTOMY SNARE SENSATION SHORT THROW MEDIUM OVAL-FLEXIBLE; SNARE, FLEXIBLE

Catalog Number M00562670

Device Problems Difficult to Open or Close (2921); Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

Snare was being used and malfunctioned, unable to open or close.Fda safety report id # (b)(4).

• Brand Name: SINGLE USE POLYPECTOMY SNARE SENSATION SHORT THROW MEDIUM OVAL-FLEXIBLE
• Type of Device: SNARE, FLEXIBLE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION
• MDR Report Key: 12771061
• MDR Text Key: 280581325
• Report Number: MW5105153
• Device Sequence Number: 1
• Product Code: FDI
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: M00562670
• Device Lot Number: 27805976
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1