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

Catalog Number CD001

Device Problem Component Missing (2306)

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

Event Date 10/02/2018

Event Type  malfunction  

Event Description

When the endocatch was opened, there was no bag.

• Brand Name: INZII RETRIEVAL SYSTEM
• Type of Device: LAPAROSCOPE, GENERAL, PLASTIC
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES CORPORATION; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 8050495
• MDR Text Key: 126526855
• Report Number: 8050495
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/01/2018

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: Health Professional
• Device Catalogue Number: CD001
• Device Lot Number: 1331627
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/01/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/01/2018
• Event Location: Hospital
• Date Report to Manufacturer: 11/08/2018
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/08/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 9125 DA
• Patient Weight: 121