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	05/05/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event product was returned to applied medical for evaluation.Upon inspection, engineering was able to confirm the complainant's experience of a fractured cannula.The wall thickness of the cannula was measured and was found to be uneven.The likely root cause of the fracture is the uneven cannula wall thickness, which occurred during the injection molding process of the cannula.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.As part of this process, applied medical has implemented process enhancements intended to further minimize the potential for this type of incident to occur.This report represents the initial and final report.
Event or Problem Description
Procedure performed: robotic assisted reconstruction abdominal wall.Event description: (b)(4) addresses event 1 of 2.(b)(4) addresses event 2 of 2."the surgeon was performing the case on (b)(6) 2017, when the trocar broke in half during the procedure.The pieces of the product were retrieved and the patient was not harmed.Unfortunately, there were no further details available at the time of the procedure." type of intervention: na.Patient status: no patient injury.
Additional Manufacturer Narrative
This report is to follow-up medwatch report # (b)(4).
Event or Problem Description
Additional information received via medwatch report# (b)(4) received on september 12, 2017: "event desc: patient underwent a robotic assisted recurrent inguinal hernia repair.During the case, the 12mm x 150mm trocar broke in half.All parts retrieved and there was no harm to the patient.Per reporter, the product was returned to applied medical.The final resolution product will be analyzed and a replacement will be provided.What was the original intended procedure? robotic assisted inguinal hernia repair.Device usage problem: device failed (e.G broke, couldn't get it to work or stopped working.".

• 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: 6774243
• Report Number: 2027111-2017-01914
• Device Sequence Number: 11079469
• Product Code: GCJ
• UDI-Device Identifier: 00607915125035
• UDI-Public: (01)00607915125035(17)200209(30)01(10)1288642
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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,Followup
• Report Date (Section B): 10/06/2017

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: 02/09/2020
• Device Model Number: CTF71
• Device Catalogue Number: 101470688
• Device Lot Number: 1288642
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/24/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/11/2017
• Supplement Date Received by Manufacturer: 07/11/2017
• Initial Report FDA Received Date: 08/08/2017
• Supplement Report FDA Received Date: 10/07/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 65 YR
• Patient Weight: 77