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	06/27/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event device has been returned to applied medical.A follow-up report will be sent upon completion of investigation.
Event or Problem Description
Procedure performed: lap gastric bypass.Event description: "near the end of the case the tip of the cannula broke off in the patient when torque was placed by the surgeon.All of the trocar was able to be removed from the patient.No further injury happened to their knowledge." additional information received via email from account manager associate on (b)(6) 2018: surgeon was torquing the trocar while operating and it broke off.It was a normal insertion.This port was an ancillary port during a "straight stick" non-robotic case.Type of intervention: "all of the trocar was able to be removed from the patient." patient status: no patient injury.
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation along with a small plastic fragment.Visual inspection confirmed the complainant's experience of a fractured cannula.Based on the condition of the returned unit and the description of the event, it is likely that the reported event was caused by a combination of the material and uneven wall thickness of the cannula.The material can become brittle when exposed to a lipid saturated environment for long duration of time.The uneven wall thickness could cause the cannula to be more susceptible to damage.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.

• 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: 7708414
• Report Number: 2027111-2018-00244
• Device Sequence Number: 1015514
• Product Code: GCJ
• UDI-Device Identifier: 00607915125035
• UDI-Public: (01)00607915125035(17)200404(30)01(10)1292909
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/08/2018

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: 04/04/2020
• Device Model Number: CTF71
• Device Catalogue Number: 101470688
• Device Lot Number: 1292909
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/17/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/27/2018
• Supplement Date Received by Manufacturer: 06/27/2018
• Initial Report FDA Received Date: 07/20/2018
• Supplement Report FDA Received Date: 08/08/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1