MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES CTR71, KII 12X150 Z-THR OPT SEP SYS 6/BX; GCJ

Model Number	CTR71
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/20/2017
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 operative laparoscopy event description: cer 1 of 2: 2017-1481 cer 2 of 2: 2017-1482 "the trocar broke while trying to penetrate the abdominal cavity.It was a clean break.Both pieces were recovered.Patient was fine.The pieces fell in the patient but both pieces were recovered.They collected the pieces and gave it to the appropriate team member.They opened up a new trocar and finished the procedure" additional information was received via email on friday 28july2017 at 9:25 am from user facility: attached pictures showed that it broke in half at the shaft.The name of the procedure is robotic assisted operative laparoscopy.Item used to penetrate abdominal cavity, shaft broke in half, broken half retrieved from abdominal cavity intact.Lot # is 1288495.Not sure if there are any other devices being used at the time such as the scope.Type of intervention: opened up a new trocar and finished the procedure.Patient status: no patient injury.

• Brand Name: CTR71, KII 12X150 Z-THR OPT SEP SYS 6/BX
• Common Device Name: GCJ
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 6808787
• Report Number: 2027111-2017-01948
• Device Sequence Number: 1568798
• Product Code: GCJ
• UDI-Device Identifier: 00607915125042
• UDI-Public: (01)00607915125042(17)200206(30)01(10)1288495
• Combination Product (Y/N): N
• Initial Reporter State: MT
• Initial Reporter Country: US
• PMA/510(K) Number: K060096
• 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): 08/21/2017

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: 02/06/2020
• Device Model Number: CTR71
• Device Catalogue Number: 101470675
• Device Lot Number: 1288495
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/09/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/27/2017
• Initial Report FDA Received Date: 08/21/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1