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

Model Number CD003

Device Problem Activation, Positioning or Separation Problem (2906)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/18/2019

Event Type  malfunction  

Event Description

Specimen bag failure, prior to specimen being placed in the bag, after the bag was in the body, bag did not deploy correctly.The wire popped out.There was no harm to the patient.

Event Description

Specimen bag failure, prior to specimen being placed in the bag, after the bag was in the body, bag did not deploy correctly.The wire popped out.There was no harm to the patient.

• 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: 8490979
• MDR Text Key: 141178318
• Report Number: 8490979
• 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
• Type of Report: Initial,Followup
• Report Date: 03/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CD003
• Device Lot Number: 1345533
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/19/2019
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/20/2019
• Event Location: Hospital
• Date Report to Manufacturer: 04/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 18250 DA