MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES CTB71, KII 12X150MM SHLD BLD Z-THR, 6/BX; GCJ

Model Number	4
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/04/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event unit was not returned to applied medical for evaluation.Based on the photographs that were received, engineering was able to confirm the complainant's experience of a fractured cannula.However, in the absence of the subject device, it is difficult to determine the root cause of the event.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 continuous process, applied medical is currently researching possible 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: robotics hysterectomy.Event description: this is the 2nd incident that occurred relating to (b)(4) (medwatch no.2027111-2017-01792).The surgeon docked the robot, put the robotic camera clamp on the trocar, and inserted the camera.As they were moving camera around, the trocar cannula cracked in half about 1/3 of the way up from the distal end of the cannula in a clean fashion.Products may be able to return but risk management needs to hold onto products until they can be released.Types of intervention: na.Patient status: no patient injury.

• Brand Name: CTB71, KII 12X150MM SHLD BLD Z-THR, 6/BX
• Common Device Name: GCJ
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 6596112
• Report Number: 2027111-2017-01793
• Device Sequence Number: 802829
• Product Code: GCJ
• UDI-Device Identifier: 00607915125066
• UDI-Public: (01)00607915125066(17)190712(30)01(10)1274605
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: 4
• 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): 05/26/2017

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: Physician
• Device Expiration Date: 07/12/2019
• Device Model Number: 4
• Device Catalogue Number: 4
• Device Lot Number: 1274605
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/04/2017
• Initial Report FDA Received Date: 05/26/2017
• Patient Sequence Number: 1