MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES CTF71, KII FIOS 12X150MM Z-THREAD, 6BX; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number	CTF71
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/07/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event unit is anticipated to return to applied medical for evaluation.A follow-up report will be sent upon completion of investigation.
Event or Problem Description
Procedure performed: robotic assisted thoracotomy.Event description: the camera port was removed at the end of the case and it was noted that the trocar was broke.The trocar was removed intact from the patient.It is unknown what brand/model clamp was used with the robot.There were no issues noted with placement of the port.No patient injury.The device is available for return.The device will be returned as is to prevent further damage of the unit before evaluation.Type of intervention: the broken trocar was removed at the end of the case and it was noted that it was broke.Patient status: no patient injury occurred associated with the complaint event.
Additional Manufacturer Narrative
The event unit was not returned to applied medical for evaluation.However, a photograph of the event unit was provided to applied medical, which confirmed the complainant¿s experience of a broken cannula.In the absence of the event unit, it is difficult to determine the exact root cause of the event.The probability and criticality of harm resulting from this failure have been evaluated and were found to be at an acceptable level.
Event or Problem Description
Procedure performed: robotic assisted thoracotomy.Event description: the camera port was removed at the end of the case and it was noted that the trocar was broke.The trocar was removed intact from the patient.It is unknown what brand/model clamp was used with the robot.There were no issues noted with placement of the port.No patient injury.The device is available for return.The device will be returned as is to prevent further damage of the unit before evaluation.Type of intervention: the broken trocar was removed at the end of the case and it was noted that it was broke.Patient status: no patient injury occurred associated with the complaint event.

• Brand Name: CTF71, KII FIOS 12X150MM Z-THREAD, 6BX
• Common Device Name: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 8906521
• Report Number: 2027111-2019-00559
• Device Sequence Number: 2538364
• Product Code: GCJ
• UDI-Device Identifier: 00607915125035
• UDI-Public: (01)00607915125035(17)211216(30)01(10)1343912
• Combination Product (Y/N): N
• Initial Reporter State: LA
• 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): 10/23/2019

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: 12/16/2021
• Device Model Number: CTF71
• Device Catalogue Number: 101470688
• Device Lot Number: 1343912
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 08/07/2019
• Supplement Date Received by Manufacturer: 08/07/2019
• Initial Report FDA Received Date: 08/19/2019
• Supplement Report FDA Received Date: 10/23/2019
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ROBOT, CAMERA