MAUDE Adverse Event Report: STERIS / UNITED STATES ENDOSCOPY GROUP, INC. STERIS ROTH NET RETRIEVER - SELECT; SNARE, FLEXIBLE

Catalog Number 00711170

Device Problems Difficult to Open or Close (2921); Material Twisted/Bent (2981)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/18/2020

Event Type  Injury  

Event Description

Roth net kinked on the top and would not close all of the way during an endo procedure.No harm to patient.

• Brand Name: STERIS ROTH NET RETRIEVER - SELECT
• Type of Device: SNARE, FLEXIBLE
• Manufacturer (Section D): STERIS / UNITED STATES ENDOSCOPY GROUP, INC. ; mentor OH 44040
• MDR Report Key: 10836641
• MDR Text Key: 216336612
• Report Number: MW5097835
• Device Sequence Number: 1
• Product Code: FDI
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 10/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/12/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/12/2022
• Device Catalogue Number: 00711170
• Device Lot Number: 1912761
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 50 YR