MAUDE Adverse Event Report: US ENDOSCOPY GROUP, INC. ROTH NET RETRIEVER; LAPAROSCOPE, GENERAL AND PLASTIC SURGERY

Catalog Number 00711170

Device Problem Difficult to Open or Close (2921)

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

Event Date 02/25/2020

Event Type  malfunction  

Event Description

Roth net would not open.Fda safety report id# (b)(4).

• Brand Name: ROTH NET RETRIEVER
• Type of Device: LAPAROSCOPE, GENERAL AND PLASTIC SURGERY
• Manufacturer (Section D): US ENDOSCOPY GROUP, INC.
• MDR Report Key: 9779982
• MDR Text Key: 182215007
• Report Number: MW5093484
• Device Sequence Number: 1
• Product Code: GCJ
• 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: 02/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/02/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/30/2022
• Device Catalogue Number: 00711170
• Device Lot Number: 1915049
• 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: 64 YR
• Patient Weight: 84