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

Model Number	GTK17
Medical Device Problem Code	Material Perforation (2205)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/05/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No product is being returned for evaluation but a lot number is provided.A device history report is to be reviewed by engineering.A final report will be sent once the results have been analyzed.
Event or Problem Description
Procedure performed- "fibroid removal" (b)(4)."contained extraction system was being used to retain uterine fibroids which were removed from patient's uterus.On removal of the extraction system, the bag broke.A small piece of bag was found on the sterile field.The procedure was completed with no harm to the patient.Device usage problem: device failed (e.G.Broke, couldn't get it to work or stopped working?" additional information was received via email on october 11.2017 from the risk manager at (b)(6)."unfortunately, all of the information i had was submitted in the medwatch report.I do not have anything further to add." type of intervention - "the procedure was completed with no harm to patient.Patient status - "no harm to the patient.".
Additional Manufacturer Narrative
The event unit was not returned to applied medical for evaluation.In the absence of the subject device, it is difficult to determine the root cause of the event.Applied medical will continue to monitor its vigilance system for trends and take appropriate actions, as necessary, to ensure the performance and safety of its products.This document is to follow up on medwatch # (b)(4).

• 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: 6997002
• Report Number: 2027111-2017-02099
• Device Sequence Number: 1005309
• Product Code: GCJ
• UDI-Device Identifier: 20607915134826
• UDI-Public: (01)20607915134826(17)191109(30)01(10)1292020
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K142427
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/15/2017

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: Other
• Device Expiration Date: 11/09/2019
• Device Model Number: GTK17
• Device Catalogue Number: 700314020
• Device Lot Number: 1292020
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/06/2017
• Supplement Date Received by Manufacturer: 10/06/2017
• Initial Report FDA Received Date: 11/02/2017
• Supplement Report FDA Received Date: 11/15/2017
• Patient Sequence Number: 1