MAUDE Adverse Event Report: US ENDOSCOPY GROUP, INC. ROTHNET RETRIEVER; SNARE, FLEXIBLE

Catalog Number 00711170

Device Problems Mechanical Problem (1384); Therapeutic or Diagnostic Output Failure (3023)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/22/2020

Event Type  malfunction  

Event Description

Two roth retrieval nets malfunctioned during procedure.One would not detach from supply bag and the other would not fully open.Fda safety report id # (b)(4).

• Brand Name: ROTHNET RETRIEVER
• Type of Device: SNARE, FLEXIBLE
• Manufacturer (Section D): US ENDOSCOPY GROUP, INC.; mentor OH 44060
• MDR Report Key: 9769602
• MDR Text Key: 181634748
• Report Number: MW5093352
• Device Sequence Number: 2
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 02/25/2020
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 00711170
• 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?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 81 YR