MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES GTK17, ALEXIS CES W 12X100 KII BAL BLNT; GCJ

Model Number	4
Medical Device Problem Code	Material Perforation (2205)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/30/2015
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event unit was not returned and could not be evaluated.In the absence of the subject device, it is difficult to determine the exact root cause.A review of the manufacturing records for the most probable lots indicated that the products passed all manufacturing and quality inspections.Although the exact root cause of the incident could not be confirmed, the likely root cause may be due to use error.It is possible that the inexperience played a role in the bag tearing.Based on the customer experience and information obtained from clinical, there are several scenarios that could lead to the ces bag tearing: as the surgeon was inserting the ces bag into the thoracic cavity, the bag was nicked/stressed by a sharp instrument; as the surgeon attempted to retrieve the un-morcellated specimen, excess force was used to pull out the ces bag; or an improper/weak seal was formed during the manufacturing of the ces bag.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.In accordance to 21 cfr 803.56, if we obtain additional information, which was not known or was not available when the initial report was submitted, then the supplemental report will be submitted to the fda.
Event or Problem Description
Vats lobectomy - "surgeon placed device into thoracic cavity.Surgeon placed specimen in the device.Surgeon removed white ring of device from the thoracic cavity, and proceeded to pull the device.Device split along bottom seem whilst surgeon was pulling the device.Device was removed, and specimen then removed using forceps".Intervention - "unknown".Patient status - "no complications".

• Brand Name: GTK17, ALEXIS CES W 12X100 KII BAL BLNT
• Common Device Name: GCJ
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 6368590
• Report Number: 2027111-2017-01420
• Device Sequence Number: 768456
• Product Code: GCJ
• UDI-Device Identifier: 20607915134826
• UDI-Public: (01)20607915134826(17)180408(30)01(10)1249613
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: 4
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/01/2017

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
• Operator of Device: Health Professional
• Device Expiration Date: 04/08/2018
• Device Model Number: 4
• Device Catalogue Number: 4
• Device Lot Number: 1249613
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/31/2015
• Initial Report FDA Received Date: 03/01/2017
• Patient Sequence Number: 1