MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES CD001, 10MM RETRIEVAL SYS, 10BX; GCJ

Model Number 12

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The event unit was returned for evaluation.Upon observation, engineering was able to confirm that the bag was missing.A review of the device history records for this lot confirmed that the unit passed all manufacturing and quality inspections.The root cause of the bag missing is likely re-actuation.Engineering found damage on an internal component that suggests the device had been deployed at least once before.Applied medical will continue to monitor its vigilance system for trends and take appropriate actions as necessary.This report is being filed as a result of a re-review of applied medical complaints received between june 1, 2014 and may 31, 2016.This retrospective review was associated with a quality management system (qms) compliance action plan developed and presented to fda to address an april 10, 2015 warning letter.Applied medical has revised its mdr reporting criteria to be more conservative and has improved complaint handling and mdr reporting processes.The reviews ensured that recent reportable events were appropriately identified and reported to the designated regulatory authority(ies).This report, which represents the initial and final reports combined, is being submitted based on the findings of that retrospective review.

Event Description

Procedure performed unknown - "inzii retrieval system was used in lap procedure, upon deployment of the system did not have a retrieval bag, just th metal holder and cord it supposed to be connected with.Remaining 6 inzii retrieval systems with the same lot were inspected visually, and all have an inzii bag ready in the introducer." patient status - "ok".

• Brand Name: CD001, 10MM RETRIEVAL SYS, 10BX
• Type of Device: GCJ
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• Manufacturer Contact: loananh nguyen ; 22872 avenida empresa; rancho santa margarita, CA 92688 ; 9497138233
• MDR Report Key: 6390200
• MDR Text Key: 69443748
• Report Number: 2027111-2017-01556
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 00607915117382
• UDI-Public: (01)00607915117382(17)180521(30)01(10)1246502
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: 12
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 05/21/2018
• Device Model Number: 12
• Device Catalogue Number: 12
• Device Lot Number: 1246502
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/10/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/17/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: KII TROCARS