MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES CORPORATION INZII RETRIEVAL SYSTEM; LAPAROSCOPE, GENERAL PLASTIC SURGERY

Model Number CD003

Device Problems Break (1069); Activation, Positioning or Separation Problem (2906); Device Fell (4014)

Patient Problem Exposure to Body Fluids (1745)

Event Date 05/14/2019

Event Type  malfunction  

Event Description

When using the universal retrieval system.The bag broke twice when trying to deploy which lead to lead to the specimen being dropped out into the cavity and the need for multiple bags.

• Brand Name: INZII RETRIEVAL SYSTEM
• Type of Device: LAPAROSCOPE, GENERAL PLASTIC SURGERY
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES CORPORATION; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 8711849
• MDR Text Key: 148428566
• Report Number: 8711849
• Device Sequence Number: 1
• Product Code: GCJ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 06/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CD003
• Device Lot Number: 1321496
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/05/2019
• Event Location: Hospital
• Date Report to Manufacturer: 06/19/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 16790 DA