MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES CORP. INZII RETRIEVAL SYSTEM

Model Number 362264

Device Problem Difficult to Open or Close (2921)

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

Event Date 02/26/2019

Event Type  malfunction  

Event Description

Inzii retrieval system, ref# cd0004, lot# 1338383, exp.Date: 2021-10-14, m# 3620264, on a robotic partial nephrectomy yesterday and the bag extended but would not open.Opened another and it worked fine.No patient injury noted.

• Brand Name: INZII RETRIEVAL SYSTEM
• Type of Device: INZII RETRIEVAL SYSTEM
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES CORP.; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 8409719
• MDR Text Key: 138547139
• Report Number: MW5084796
• 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: 02/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/14/2021
• Device Model Number: 362264
• Device Catalogue Number: CD004
• Device Lot Number: 1338383
• 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