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

Model Number	1
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/28/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event product was not returned to applied medical for evaluation.Based on the description of the event, it is likely that the fractured cannula was caused by 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 2 of 2, (b)(4) addresses event 1 of 2."the surgeon was performing the procedure on the patient.During re-positioning of the patient, a nurse noticed that the trocar appeared to fall out of the patient.When examined closer the trocar broke in half, while it was still in the patient.The product was retrieved and there was no harm to the patient." additional information received via email from contract coordinator, on (b)(6) 2017: laparoscopic instruments were inserted into the trocar.The cannula broke, but the break was clean.The da vinci robot was in use during the surgery.It is not sure if the medical clamp was in use with the trocar.Additional information received via email from contract coordinator, on (b)(6) 2017: "there were graspers and energy device inserted into the trocar during the procedure.The graspers are from [a competitor].I am unsure of the model numbers.I am unsure of the energy device that was in use when this occurred.However, the staff believes it may have been a [competitor's energy device]." 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 03oct2017: "patient underwent a robotic assisted abdominal wall reconstruction.While attempting to reposition, the trocar broke in half.The device was retrieved with no harm to the patient.The product was returned to the vendor for analysis.What was the original intended procedure" robotic assisted abdominal wall reconstruction 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: 6778893
• Report Number: 2027111-2017-01915
• Device Sequence Number: 11205626
• Product Code: GCJ
• UDI-Device Identifier: 00607915125035
• UDI-Public: (01)00607915125035(17)200321(30)01(10)1291799
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: 1
• 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: 03/21/2020
• Device Model Number: 1
• Device Catalogue Number: 1
• Device Lot Number: 1291799
• Was Device Available for Evaluation?: No
• 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: 08/09/2017
• 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: 56 YR
• Patient Weight: 139