MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES CTF71, KII FIOS 12X150MM Z-THREAD, 6BX; GCJ

Model Number	CTF71
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/31/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event product 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.The probability and criticality of harm resulting from this failure mode have been evaluated and were found to be at an acceptable level.Applied medical continuously seeks to improve the form, function and ease of use of its products and will continue to monitor its vigilance system for trends and take appropriate actions as necessary.This report represents the initial and final report.
Event or Problem Description
Laparoscopic tubal ligation - "the customer contacted me stating that when the surgeon inserted the trocar, and when he went to remove the instrument he noticed that it would not come out easily.When he looked with the camera, the bottom half of the trocar had broken off and was laying in the abdomen.The surgeon was able to retrieve the item from the abdomen while we were on the phone." additional information received via email from or manger via email on 02-june-2017: "surgeon first noticed that port was in 2 pieces when removing scope, no articulation noted, 1 piece was retrieved from abdominal cavity, no obvious injury noted, port was primary umbilical port, no robot, varies needle was used for insufflation prior to port insertion" type of intervention - the surgeon was able to retrieve the item from the abdomen.Patient status - "no obvious injury noted".

• Brand Name: CTF71, KII FIOS 12X150MM Z-THREAD, 6BX
• Common Device Name: GCJ
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 6622965
• Report Number: 2027111-2017-01838
• Device Sequence Number: 13650183
• Product Code: GCJ
• UDI-Device Identifier: 00607915125035
• UDI-Public: (01)00607915125035(17)200106(30)01(10)1286840
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K041795
• 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
• Report Date (Section B): 06/08/2017

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: Physician
• Device Expiration Date: 01/06/2020
• Device Model Number: CTF71
• Device Catalogue Number: 101470688
• Device Lot Number: 1286840
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/31/2017
• Initial Report FDA Received Date: 06/08/2017
• Patient Sequence Number: 1