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

Model Number CD004

Device Problem Difficult to Open or Close (2921)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/15/2017

Event Type  malfunction  

Event Description

Deflector bag would not open and it was preventing the procedure from being formed.Another deflector bag was used to complete the procedure.Product had patient contact but no patient harm.Manufacturer response: for inzil retrieval 12/15mm, (brand not provided) (per site reporter).Reported.Waiting for return box.

• 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: 7373249
• MDR Text Key: 103560890
• Report Number: 7373249
• 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: User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 03/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: CD004
• Device Lot Number: 1307125
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/05/2018
• Event Location: Hospital
• Date Report to Manufacturer: 03/05/2018
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/27/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1