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

Model Number	CTF71
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/02/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation.Visual inspection confirmed the complainant's experience of a cracked cannula tip.Scratch marks were also observed on the inner surface of the cannula.Based on the condition of the returned unit, it is likely that the crack on the cannula tip was caused by contact with a hard surface or an instrument.However, the exact root cause could not be confirmed.It is likely that the scratches were caused by contact from a sharp instrument.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.Based on the event description received during intake of the complaint, the event was deemed not reportable.After evaluation by engineering, the event is deemed reportable.This report represents the combined initial and final.
Event or Problem Description
Procedure performed: robotic.Event description: "dr [name] was inserting the trocar.Cracked on tip of cannula while inserting.100% sure nothing was left inside the patient.No particulation".Patient status: "fine".

• 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: 7075584
• Report Number: 2027111-2017-02087
• Device Sequence Number: 1108794
• 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: KY
• 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): 12/01/2017

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: Health Professional
• 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: 10/31/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/05/2017
• Initial Report FDA Received Date: 12/01/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1